Site Lead Quality Manager & Regulatory Affairs (QM/RA)

Kyowa Kirin

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary of Job: The North America Head of Scientific Communications is a senior leadership role within NA Medical Affairs responsible for setting the strategic direction, oversight, and governance of scientific communications across the regional portfolio. This role ensures the delivery of high-quality, compliant, and impactful scientific communications that support evidence dissemination, medical education, and scientific exchange throughout the product lifecycle. The role provides leadership for regional publication strategy and execution, field medical resources, medical education content, digital scientific communications, congress activities, and regional medical review processes. The role leads and develops a high-performing scientific communications team and serves as a key strategic partner to Medical Affairs therapeutic area leaders, commercial team and cross-functional stakeholders. As a catalyst for innovation, the NA Head of Scientific Communications continuously evaluates emerging digital channels, data-driven insights, and evolving stakeholder engagement preferences to ensure Medical Affairs remains at the forefront of scientific exchange. This includes leveraging modern communication platforms and formats—including social media, podcasts, and other digital channels—to meet the evolving information needs of healthcare professionals, scientific experts, and key opinion leaders. Essential Functions: Future Pipeline Expansion & Capability Building * Proactively prepare NA Scientific Communications to support future pipeline expansion, including new therapeutic areas, indications, modalities, and lifecycle stages. * Anticipate scientific communications needs associated with pipeline progress and evolving portfolio complexity, including early asset planning, launch readiness, and post-launch evidence dissemination. * Design scalable scientific communications approaches, processes, and resourcing models that can flex with portfolio expansion. * Partner with Global Medical Affairs and Clinical Development to ensure early alignment of scientific narratives, data generation plans, and publication strategy for pipeline assets. * Identify capability gaps and lead continuous improvement initiatives across scientific communications, including talent development, vendor partnerships, and operational excellence.  Strategic Leadership & Governance * Develop and own the regional scientific communications strategy across multiple products, aligned with global medical strategy, portfolio priorities, and North America Medical Affairs objectives. * Establish and maintain regional governance frameworks, standards, and best practices for scientific communications across channels and formats. * Serve as a senior scientific communications advisor to North America Medical Affairs leadership and therapeutic area leads. * Ensure compliance with internal SOPs, Good Publication Practice (GPP), ICMJE guidelines, and all applicable regulatory, legal, and compliance requirements.  Publications & Evidence Dissemination * Oversee regional publication planning and execution, including abstracts, manuscripts, posters, oral presentations, and plain language summaries. * Ensure timely, high-quality execution of regional publication plans in collaboration with global partners, investigators, and external authors. * Provide strategic oversight of publication vendors and agencies, including scope, budgeting, and performance management.  Scientific Content & Medical Materials * Lead development and lifecycle management of regional scientific narratives, lexicons, and key data-driven messages. * Oversee creation, approval, and maintenance of regional field medical materials, including slide decks, FAQs, disease education materials, and data summaries. * Ensure all materials are scientifically accurate, strategically aligned, audience-appropriate, and tailored to regional needs.  Medical Education & Congress * Oversee scientific content for regional medical education, insight generation initiatives, advisory boards, and peer-to-peer scientific exchange. * Provide scientific communications leadership for regional congress strategy and execution, including content development, scientific booth materials, and symposia support. * Partner closely with Field Medical and Medical Education teams to align content with scientific objectives and stakeholder insights. Digital Scientific Communications * Provide strategic oversight of regional digital scientific assets, including modular and omnichannel-ready content, congress digital materials, and online educational resources. * Partner with digital and omnichannel teams to ensure scientific rigor, consistency, and effective data visualization across platforms.  Medical Review & Compliance Oversight * Lead and oversee regional medical review processes to ensure efficient, compliant, and high-quality review of scientific communications materials. * Serve as a senior medical/scientific reviewer and escalation point for complex scientific, regulatory, or compliance-related issues. * Drive continuous improvement of review workflows and cross-functional collaboration.  People Leadership & Talent Development * Lead, coach, and develop a team of scientific communications professionals, fostering a culture of scientific excellence, accountability, and collaboration. * Set clear objectives, provide ongoing performance feedback, and support professional development for direct reports. * Build and sustain a high-performing scientific communications function capable of supporting a growing and evolving portfolio. * Anticipate future portfolio and pipeline needs to inform thoughtful expansion of the scientific communications team over time. * Define future role profiles and succession plans to ensure the organization scales effectively as new assets and therapeutic areas are added to the portfolio.  Decision-Making Authority * Accountable for regional scientific communications strategy, priorities, and execution across the North America portfolio. * Final scientific approval authority for regional scientific communications materials within established governance and SOPs. * Authority to manage external vendors and agency partners. * Escalation authority for complex scientific, compliance, or reputational risk issues related to scientific communications. Strategic Partnerships & Cross-Functional Leadership * Serve as a strategic partner to North America Medical Affairs Leadership, Therapeutic Area Heads, Field Medical, Global Medical Affairs, and Global Scientific Communications to ensure alignment of scientific communication strategies and execution. * Collaborate closely with Clinical Development, HEOR, Regulatory Affairs, Legal, Compliance, Commercial, Digital, Omnichannel, and Alliance partners to develop and deliver impactful, compliant scientific communications and medical education initiatives. * Represent North America Scientific Communications on cross-functional governance committees, leadership forums, and strategic initiatives, providing scientific communications expertise and influencing organizational priorities. * Foster strong alignment between regional and global scientific communications strategies, ensuring consistency, operational excellence, and effective dissemination of scientific evidence across the product lifecycle. * Build and maintain productive relationships with external stakeholders, including investigators, scientific authors, vendors, and agency partners, to support high-quality scientific communication deliverables. Subordinates: Medical Communication Directors (2) and Senior Manager, PRC/MRC Job Requirements: Education Advanced Scientific or Clinical Degree: An earned Ph.D., Pharm.D., or M.D. in a relevant life sciences, biomedical, or clinical discipline is strictly required. Experience * Minimum 12+ years of experience in Medical Affairs, or related roles within pharmaceutical or biotechnology organizations, at least 6 years in Scientific/Medical Communication. * Senior leadership experience managing scientific communications teams and leading complex, cross-functional, matrixed initiatives at regional or global scale. * Extensive oversight of end-to-end scientific communications activities, including publications, medical education, field medical materials, congress strategy, and digital scientific content. * Strong understanding of publication planning standards, medical governance, and regulatory and compliance requirements within a highly regulated environment. * Experience serving as a strategic partner to Medical Affairs leadership, with ability to influence cross-functional stakeholders and align scientific communication strategies with enterprise objectives. * Background contributing to transformation initiatives in Medical Affairs, including modernization of scientific communications and evolution toward digital and omnichannel engagement models. * History of building, leading, and developing high-performing, multidisciplinary teams, including mentorship of managers and senior scientific communications professionals. * Experience operating within global or regional matrix organizations, ensuring alignment between regional execution and global scientific communications strategy.   Technical Skills & Competencies * Deep understanding of Medical Affairs operating models, governance structures, and the role of Medical Affairs across the product lifecycle, including its interface with Clinical Development, Regulatory, and Commercial functions. * Strong expertise in strategic planning, portfolio prioritization, and resource allocation within complex, global matrix organizations. * Comprehensive knowledge of Medical Affairs planning and execution, including scientific communications, publication planning, medical education, field medical strategy, evidence generation, and investigator-sponsored research activities. * Solid understanding of clinical development processes, regulatory requirements, compliance standards, and industry guidelines governing Medical Affairs operations. * Experience establishing and optimizing governance frameworks, operational processes, and performance metrics that enhance effectiveness, consistency, and scalability of Medical Affairs activities. * Ability to influence and align senior stakeholders across global and regional organizations without direct authority, driving consensus in highly matrixed environments. * Strong strategic acumen and business orientation, with the ability to translate enterprise priorities into actionable plans, clear governance structures, and measurable outcomes. * Advanced communication and executive presentation skills, with the ability to engage senior leadership and support informed, cross-functional decision-making. * Strong analytical capability, leveraging data, insights, and performance indicators to support prioritization, resource decisions, and continuous improvement. * Proficiency in business planning, portfolio tracking, and collaboration tools, with strong command of Microsoft Office applications (PowerPoint, Excel, and related tools).  Non-Technical Skills Ability to thrive in a fast-paced environment while managing ambiguity effectively. Strong work ethics are required. Passion for personal learning and professional development. Cultural sensitivity and adaptability within multinational organizations. The anticipated salary for this position will be $250,000 to $286,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-JC1

TOBLOR Consulting AB

Camurus is an international, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for improving the lives of patients with severe and chronic diseases. New drug products with best-in-class potential are conceived based on the company’s proprietary FluidCrystal® technology and its extensive R&D expertise. The R&D pipeline includes products for the treatment of dependence, pain, cancer, and endocrine diseases. Camurus has operations across Europe, the US, and Australia, with headquarters in Lund Sweden. The company’s shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com and LinkedIn. In this role you will get the opportunity to work with committed colleagues in a collaborative team. Camurus is a rapidly growing and innovative company, and you will have a strong impact on the way we work with our outsourced manufacturing activities. We are looking for an experienced Senior Outsourcing Manager to join our Manufacturing Operations team. In this role, you will be responsible for driving outsourcing programs for injectable pharmaceutical products to Contract Manufacturing Organizations (CMOs), with a particular focus on late-stage development projects. As Senior Outsourcing Manager, you will serve as the primary interface between Camurus and external manufacturing partners. This is a true Project Management role where you will ensure successful project execution from technology transfer through start of commercial production. You will work closely with internal stakeholders and external partners to secure reliable, compliant, and efficient delivery of the project. You will report to the Director Manufacturing Operations. Main responsibility Among others, your responsibilities will include: · Develop and manage project plans, timelines, and milestones for technology transfer, process development, process validation, and manufacturing readiness activities together with CMO partners. · Drive day-to-day collaboration with CMOs and ensure agreed deliverables, timelines, and performance targets are achieved. · Lead operational meetings and steering committee meetings with external manufacturing partners. · Identify risks and issues proactively and drive mitigation and resolution activities together with internal and external stakeholders. · Coordinate and manage changes with CMOs, ensuring proper documentation, implementation, and alignment with project plans and contractual commitments. · Collaborate closely with internal Camurus functions such as Quality, R&D, Regulatory Affairs and Supply Chain to ensure successful project execution. · Ensure manufacturing activities are conducted in accordance with applicable GMP requirements and regulatory expectations. · Support continuous improvement initiatives related to outsourcing, external manufacturing operations, and CMO performance. Candidate profile We are looking for a professional with extensive experience from pharmaceutical manufacturing operations including outsourcing and CMO management. You hold a Master’s degree in Engineering, Life Sciences, or a related scientific discipline. You have a solid understanding of GMP-regulated manufacturing environments and a proven track record of managing outsourcing programs and external manufacturing partners within the pharmaceutical or biotech industry. Experience from late-stage development, technology transfer and commercial manufacturing is highly valued. Experience from injectable products and combination products is considered a strong merit. As a person, you are structured, collaborative, and communicative, with a proven ability to drive complex projects and build strong relationships across multiple stakeholders. You combine a proactive and results-oriented mindset with a pragmatic and hands-on approach, while maintaining a humble and low-prestige attitude. Fluency in spoken and written and English is required. Camurus offers This a great opportunity to join a highly dynamic company during a very exciting phase of growth. Camurus has been very successful in bringing pharmaceutical products to the market – and the ambitions are not to be lowered. With a diversified project portfolio in different stages, the commercial potential is considerable. The position offers an international work environment and corporate culture, with the possibility for individual development and growth. You will have great opportunities to influence, and you will work together with highly competent colleagues, caring for each other. Camurus has almost 300 employees with the head office located in Lund. The corporate culture is driven by our core values of innovation, collaboration, ownership, quality, and passion for realizing our patient-centric commitment. Information and application For more information about this job-opening, please contact recruitment consultant Tobias Lorentzon at TOBLOR Consulting, phone: +46 735 11 10 60. You apply for this position through TOBLOR’s career site, https://career.toblor.se/, by uploading your CV and personal letter. For more information about Camurus, please visit: https://www.camurus.com/. We are looking forward to seeing your application!

Multiverse

Multiverse is the upskilling platform for AI and Tech adoption. We have partnered with 1,500+ companies to deliver a new kind of learning that's transforming today’s workforce. Our upskilling apprenticeships are designed for people of any age and career stage to build critical AI, data, and tech skills. Our learners have driven $2bn+ ROI for their employers, using the skills they’ve learned to improve productivity and measurable performance. In April 2026, we announced $70 million in strategic funding, led by Schroders Capital, with participation from StepStone Group, Lightspeed Venture Partners and General Catalyst. At an increased valuation of $2.1bn, the round makes us Europe’s first EdTech double unicorn. But we aren’t stopping there. With a strong operational footprint and 800+ employees, we have ambitious plans to continue scaling. We’re building a world where tech skills unlock people’s potential and output. Join Multiverse and power our mission to equip the workforce to win in the AI era. ABOUT MULTIVERSE Multiverse is the upskilling platform for AI and tech adoption. We partner with 1,500+ companies to deliver a new kind of learning that is transforming today's workforce. Our upskilling apprenticeships are designed for people of any age and career stage to build critical AI, data, and tech skills. Our learners have driven $2bn+ ROI for their employers — and we are just getting started. In 2022, Multiverse was granted New Degree Awarding Powers (New DAPs) by the Office for Students (OfS), making it one of a small number of providers outside the traditional university sector to hold these powers. We are now preparing for our Full DAPs end assessment — the process by which those powers are confirmed, strengthened, and placed on a permanent footing.   ROLE PURPOSE This is a high-stakes, high-visibility fixed-term role at the heart of one of Multiverse's most important regulatory processes. The Full DAPs end assessment, with a submission deadline of 26 October 2026 and a site visit in early 2027, will determine whether Multiverse retains its ability to independently award degrees beyond December 2027. As Project Lead for the Full DAPs end assessment, you will own the day-to-day delivery of the submission: auditing our current evidence base, coordinating contributions from teams across the business, and drafting the self-assessment narrative that will be reviewed by three external assessors and the OfS's Quality Assessment Committee. This is not a desk-based writing role. It requires someone who can navigate a complex organisation, hold senior stakeholders accountable, and translate regulatory language into clear internal tasks — while producing a self-assessment document that is honest, rigorous, and compelling. You will work closely with the Senior Manager, Instructional Delivery, Head of Regulatory Affairs, and our retained specialist consultancy, with regular visibility to senior leadership.   KEY RESPONSIBILITIES EVIDENCE AUDIT AND GAP ANALYSIS * Conduct a structured audit of Multiverse's current evidence base against each Full DAPs criterion (A–E), identifying gaps, weaknesses, and areas requiring corrective action * Map existing documentation — policies, committee minutes, programme records, staff development frameworks — to the relevant evidence requirements * Produce a clear gap analysis that drives the work plan for the submission, with particular attention to the corrective actions identified in the Year 1 monitoring assessment. STAKEHOLDER COORDINATION AND EVIDENCE GATHERING * Act as the central coordinator for cross-functional evidence contributions, managing and chasing stakeholders across Learning, Certification Operations, Governance, Student Engagement, and Enablement * Build and maintain a shared project tracker that gives all contributors clarity on what is needed, from whom, and by when * Work with the Enablement team to develop and document pathways for instructor engagement with the wider HE sector — including external examiner opportunities, HE partnerships, and scholarship activity — to address criterion C1 (staff scholarship and pedagogical effectiveness) * Facilitate the gathering of student voice evidence in a form that satisfies criterion A1 and D1, working with the student engagement function * Escalate blockers clearly and early to Harriet Lowe, with a proposed solution SELF-ASSESSMENT DRAFTING * Draft the self-assessment submission in the PEE structure (Policy, Explain, Evidence) for each criterion, translating Multiverse's operational reality into the OfS regulatory register * Ensure the document demonstrates honest self-criticality — a key differentiator in OfS assessments — while presenting Multiverse's progress in the strongest credible terms * Incorporate feedback from Harriet Lowe, Shenay Cantelo-Poppe and Mesma through iterative review cycles * Manage the evidence spreadsheet alongside the narrative, ensuring every claim is mapped to a specific piece of supporting documentation PROJECT MANAGEMENT * Own the project plan from June 2026 through to submission on 26 October 2026, with responsibility for on-time delivery * Prepare regular progress updates for Harriet Lowe and, where required, for senior leadership * Support site visit preparation (estimated January–February 2027) if the contract is extended, including briefing documents for staff who will meet the assessment team.   WHAT YOU'LL BRING ESSENTIAL * Experience working in or alongside a higher education quality assurance or regulatory compliance function — you understand how OfS criteria translate into operational evidence * Exceptional stakeholder management skills: you can hold people accountable to deadlines without direct authority, and know how to move things without burning relationships * Strong written communication — you can produce clear, well-structured regulatory narrative and are comfortable working in a formal register * Project management rigour: you are comfortable owning a complex workplan with multiple workstreams, dependencies and a hard deadline * Ability to read and interpret dense regulatory guidance and distil it into clear, actionable asks for internal teams DESIRABLE * Direct experience with regulatory processes, e.g DAPs assessments or OfS self-assessment submissions * Familiarity with the education sector, apprenticeship or workforce learning sector * Experience drafting or contributing to a formal quality self-assessment document (e.g. for OfS, Ofsted, QAA, or similar body) * Understanding of the FHEQ and threshold academic standards   WHY THIS ROLE MATTERS The Full DAPs end assessment is not an administrative exercise. Passing it confirms Multiverse's status as an independent degree-awarding body and protects our ability to award degrees to the thousands of apprentices on our programmes. The self-assessment document you produce will be reviewed by three external assessors, considered by the OfS's Quality Assessment Committee, and published. The Year 1 monitoring assessment identified corrective actions across four of the five criteria. This submission must demonstrate that those have been resolved — in practice, not just on paper. The person in this role will be central to making that case. This is a rare opportunity to lead a high-stakes regulatory process at a fast-moving, mission-driven organisation, with direct access to senior leadership and genuine ownership of a critical outcome. Benefits * Time off - 27 days holiday, plus 5 additional days off: 1 life event day, 2 volunteer days, 2 company-wide wellbeing days (M-Powered Weekend) and 8 bank holidays per year * Health & Wellness- private medical Insurance with Bupa, a medical cashback scheme, life insurance, gym membership & wellness resources through Wellhub and access to Spill - all in one mental health support * Hybrid work offering - for most roles we collaborate in the office three days per week with the exception of Coaches and Instructors who collaborate in the office once a month * Work-from-anywhere scheme - you'll have the opportunity to work from anywhere, up to 10 days per year * Space to connect: Beyond the desk, we make time for weekly catch-ups, seasonal celebrations, and have a kitchen that’s always stocked! Our Commitment to Diversity, Equity and Inclusion We’re an equal opportunities employer. And proud of it. Every applicant and employee is afforded the same opportunities regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. This will never change. Read our Equality, Diversity & Inclusion policy here. Our Commitment to Safeguarding Multiverse is committed to safeguarding and promoting the welfare of our learners. We expect all employees to share this commitment and adhere to our Safeguarding Policy, our Prevent Policy and all other Multiverse company policies. Successful applicants will be required to undertake at least a Basic check via the Disclosure Barring Service (DBS). For roles that will involve a Regulated Activity, successful applicants must also undergo an Enhanced DBS check, including a Children’s Barred List check and a Prohibition Order check. Roles involving Regulated Activity may interact with vulnerable groups, therefore are exempt from the Rehabilitation of Offenders Act 1974 meaning applicants are required to declare any convictions, cautions, reprimands, and final warnings. Providing false information is an offence and could result in the application being rejected or summary dismissal if the applicant has been selected, and possible referral to the police and the DBS.