Medical Affairs QC Analyst

OGT

OGT is a leading global provider of clinical and diagnostic genomic solutions. We believe in creating products and partnerships that enable clinicians to deliver personalised healthcare to patients and that empower clinical researchers to develop the next generation of precision medicines. ** This position is a fixed-term contract, ending in December 2028 ** Our Medical Affairs Scientists are knowledgeable individuals who are passionate about ensuring that OGT’s products are safe, effective, and fit for purpose, thus allowing them to be available globally and state of the art. You will play an integral role in the delivery of internal and external analytical and clinical performance data for a range of OGT products.  What you’ll be doing for us: To work as part of a team in executing tasks as directed, but not limited to, the following activities:   * Contribute to the documentation and infrastructure of the department by overseeing the writing of internal and external protocols, study plans and reports   * Participate in the design, implementation and delivery of any required studies * Identify and engage external laboratories, clinicians, and partners to obtain clinical performance data * Support and coordinate external studies, including collaboration, data sharing, and contracting activities * Collaborate with internal and external stakeholders to support project delivery * Manage and coordinate projects activities from initiation through to completion * Analyse and interpret data across diagnostic techniques and deliver scientific, clinical, and analytical reports in a timely manner * Ensure timely and accurate reporting of study results * Provide clinical/scientific input for product brochures, catalogues and other marketing materials when required * Contribute to the quality management system and infrastructure of the department by providing input into internal protocols and implementation of CAPAs, change controls and improvements * Support validation activities for team equipment and software, and support maintenance of risk management documentation in line with ISO 14971 * Provide training and support to medical affairs analysts and assistants as appropriate * Provision of analytical teaching within and outside of the medical affairs team as appropriate * Analysis of FFPE and haematological specimens using manual microscopes and automated software * Support karyotype analysis of G banding and reverse DAPI FISH images * To complete any other tasks as commensurate with the level and nature of the post as delegated by the line manager. What we are looking for in you Essential * A bachelor’s degree in molecular biology, biochemistry, genetics, biotechnology, or similar subject is required * Knowledge of FISH and/or cytogenetics techniques and their clinical applications * Understanding of clinical diagnostics, laboratory workflows, or molecular testing * Ability to engage confidently with external partners, including laboratories, clinicians, and collaborators * Proven ability to proactively drive activities forward * Experience drafting study protocols or similar technical/scientific documentation  * Understanding of study design considerations, including objectives, endpoints and data requirements  * Strong organisational and project coordination skills, managing activities from initiation through to completion  * Ability to interpret clinical or diagnostic data, including comparison across different testing methodologies  * Experience handling sensitive or clinical data, with an understanding of data quality and governance requirements  * Excellent communication skills, both written and verbal. Desirable * Cytogenetics experience in an NHS laboratory or equivalent * Experience in data acquisition, clinical studies, or external collaborations  * Experience setting up or supporting contracts, agreements, or study arrangements with external partners  * Familiarity with disease areas, sample types, and appropriate testing approaches  * Awareness of commercial or customer-facing environments, particularly in diagnostics or life sciences  * Experience supporting clinical performance evaluations, validation, or regulatory activities  * Experience in cytogenetics and or Karyotype analysis. In return you will receive:  * Competitive salary * Pension Scheme (10% non-contributory) * Private Health Insurance * Private Dental Insurance * Group Income Protection * Group Life Assurance * 25 days holiday plus UK bank holidays * High Street Discount Scheme. Application is via CV and a one-page covering letter outlining your suitability for the role, salary expectations and notice period. Please note that we will need to establish your right to work during the recruitment process.

SallyQ AB

Immedica Pharma has experienced remarkable growth in recent years and is now strengthening their Manufacturing/CMC organization with an experienced analytical expert. The Manufacturing/CMC team is responsible for overseeing all aspects of the production of Immedicas’s products, all of which are manufactured externally. This includes defining CMC strategy, ensuring regulatory compliance, and coordinating activities with CLOs and CMOs. As Senior Scientist Analytical Technology, you will play a key role in securing the quality, compliance, and lifecycle performance of analytical methods across Immedicas’s product portfolio. You will take the lead on analytical method transfers, validation activities, and continuous improvement initiatives, ensuring that our methods remain robust, efficient, and fit for purpose. This is a new role created to gather all ASAT activities; hence it gives an exceptional opportunity for someone who wants to take lead and grow with the role. You will collaborate cross‑functionally and act as a central analytical resource supporting product quality, life cycle management projects such as manufacturing tech transfers, regulatory submissions, and ongoing development needs. Since all laboratory work is conducted externally at CMOs and partner laboratories, success in this role requires strong collaboration skills, excellent communication, and the ability to build productive relationships with external partners. Main responsibilities: Act as analytical subject matter expert (SME) for Immedica’s products Own and oversee analytical method performance, including trending of analytical release and stability data Identify and drive improvements in analytical methods and control strategies Coordinate stability studies, ensuring product stability and shelf life Manage reference standards Act as analytical SME in supporting investigations, changes, CAPAs and life cycle management activities Act as analytical SME in regulatory submissions, including ownership of specifications Lead analytical method transfers, method development activities and comparability studies Collaborate closely with internal product teams and external manufacturing & laboratory partners (CMO/CLO) to ensure quality and timelines Why join? Immedica Pharma offers an innovative, dynamic workplace with short decision paths and a high degree of ownership. Being a part of the Manufacturing/CMC team means you will work with engaged colleagues in a specialist role with high visibility and influence. You will have opportunities for professional development and continuous learning in a highly competent CMC environment. Your profile You are a self‑driven analytical expert with strong pharma experience and broad scientific knowledge. You take clear ownership of your responsibilities and communicate effectively with both internal and external stakeholders. You act confidently as an SME, and are structured, quality‑focused, and improvement‑oriented. You thrive in fast-paced, hands-on environment and combine strong analytical expertise with a collaborative, business-oriented mindset. Qualifications: MSc or PhD in analytical chemistry, biotechnology, or a related field 5-10 years of experience in pharmaceutical development or manufacturing of biologics or small molecules, including GMP Experience in analytical validation, tech transfer activities and stability study setup Experience in performing a broad range of analytical methods in the laboratory, e.g. HPLC, spectroscopy, ELISA, bioassay Good understanding of statistical methods for establishing specifications and evaluating analytical outcomes Ability to interpret and implement regulatory requirements (ICH/FDA/EMA etc.) in method transfer and comparability Experience of working with external labs/CMOs Fluency in Swedish and English, both written and spoken It is a strong advantage if you also bring: Previous leadership experience, such as project management or team management Previous experience of working with QC operations Appealing? Send in an application as soon as possible. In this recruitment, Immedica are collaborating with SallyQ. For questions, contact Ellinor Crafoord, Senior Recruitment Consultant, +46793554257 or ellinor.crafoord@sallyq.se. About Immedica Immedica is a pharmaceutical company, headquartered in Stockholm, Sweden, focused on the commercialization of medicines for rare diseases within metabolic, neurology, hematology & oncology, endocrinology and specialty care. Immedica’s capabilities cover marketing and sales, compliance, pharmacovigilance, quality assurance, external manufacturing, regulatory and medical affairs as well as market access. Serving patients in more than 50 countries, Immedica is fully dedicated to helping those living with diseases which have a large unmet medical need. Immedica was founded in 2018 by investment company Impilo and buy-in management and currently employs more than 180 people across Europe, the Middle East and the US. Of these, approximately 80 are based in the headquarters in Life City, Hagastaden, Stockholm. At Immedica, our core values are the foundation of our culture and the driving force behind how we operate, innovate, and collaborate. These values guide every decision we make, shaping our commitment to patients, partners, and colleagues. Open & Honest: We foster transparency, integrity, and trust through open communication. Effective: Focused on delivering excellence, we prioritize impact and quality to make a real difference in the rare disease landscape. Empowered: We encourage collaboration and ownership, creating a supportive workplace where all team members’ contributions drive innovation and growth.

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 Medical Affairs Operations & Excellence is a senior leadership role responsible for advancing the strategic, operational, and organizational effectiveness of the North America Medical Affairs function. With regional accountability and strong partnership across Global Medical Affairs, this leader drives integrated planning, governance, resource optimization, performance management, and execution excellence to support the organization's scientific and business objectives. The role provides leadership and oversight for Medical Affairs operations and directly manages the North America Medical Affairs Project Management team. As a key member of the Medical Affairs leadership ecosystem, the Head of Medical Affairs Operations & Excellence partners closely with regional and global stakeholders to align priorities, enable cross-functional execution, optimize portfolio delivery, and foster a culture of continuous improvement, scalability, and operational rigor across the organization. Essential Functions: Medical Affairs Operations & Strategy Enablement * Lead the design, implementation, and continuous improvement of Medical Affairs operational models across North America. * Translate Medical Affairs strategy into integrated operational plans, timelines, and execution frameworks across therapeutic areas and assets. * Partner with North America Medical Affairs leadership to support annual planning, goal setting, prioritization, and resourcing decisions. * Enable effective execution across the Medical Affairs portfolio by driving clarity of roles, responsibilities, decision rights, and interdependencies. * Provide regional accountability for North America Medical Affairs systems and tools (e.g., planning, tracking, and performance management platforms), ensuring fit-for-purpose use, alignment with global standards, and continuous optimization. * Oversee North America Medical Affairs operating budgets, including planning, forecasting, tracking, and optimization of spend in partnership with Finance and Global Medical Affairs counterparts. * Oversee promotional/non-promotional review process Project Management & Execution Excellence * Oversee a team of Medical Affairs project managers responsible for planning and execution of key Medical Affairs initiatives, programs, and milestones. * Establish standardized project management methodologies, tools, and best practices across Medical Affairs. * Ensure consistent tracking, reporting, and escalation of risks, dependencies, and execution issues across the portfolio. * Drive on-time, high-quality delivery of Medical Affairs initiatives through strong governance and disciplined execution.  Governance, Processes & Ways of Working * Lead Medical Affairs governance forums and operating rhythms, including portfolio reviews, planning meetings, and leadership updates. * Establish and maintain clear processes for intake, prioritization, execution, and decision-making across Medical Affairs activities. * Partner with Regulatory, Legal, Compliance, and other functions to ensure Medical Affairs operations align with internal policies and external requirements. * Drive simplification and efficiency by identifying and addressing process gaps, redundancies, and operational pain points.  Performance Management & Insights * Define and implement performance metrics, dashboards, and reporting to track Medical Affairs execution, impact, and resource utilization. * Enable data-driven decision-making through clear insights into progress, risks, and outcomes. * Support continuous improvement by using performance insights to inform planning, prioritization, and operational enhancements. * People Leadership & Capability Building * Lead, develop, and mentor a team of Medical Affairs project managers, fostering a culture of accountability, collaboration, and operational excellence. * Build project management and operational capabilities across the Medical Affairs organization through training, coaching, and best practice sharing. * Support talent development, succession planning, and future capability needs as the portfolio and organization evolve.  Cross-Functional Leadership & Strategic Partnership * Serve as a strategic operational partner to the North America Medical Affairs Leadership Team, Therapeutic Area and Asset Leads, and Medical Affairs functional leaders. * Foster alignment, transparency, and effective execution across Medical Affairs, including Project Management, Scientific Communications, Medical Education, and Field Medical teams. * Partner closely with Clinical Development, HEOR, Regulatory Affairs, Commercial, Finance, Legal, and Compliance to enable integrated planning, decision-making, and execution. * Collaborate with the Global Medical Affairs Office Head and Global Medical Affairs Operations/Strategy counterparts to ensure alignment of regional priorities with global objectives and best practices. * Act as a key connector across functions and geographies, facilitating communication, managing interdependencies, and driving seamless execution of Medical Affairs initiatives.  Decision-Making Authority * Accountable for Medical Affairs operational frameworks, execution standards, and performance management across North America. * Authority to establish project management methodologies, tools, and reporting standards. * Operational escalation authority for execution risks, resource constraints, and cross-functional dependencies. * Input into Medical Affairs resourcing, prioritization, and organizational design decisions. Job Requirements: Education Bachelor's degree in Life Sciences, Business Administration, Project Management, or a related field required. Advanced degree in a scientific, clinical, or healthcare-related discipline strongly preferred (e.g., MD, PharmD, PhD, MSN, or equivalent).  Experience * Minimum of 12 years in the pharmaceutical/biotechnology industry, including at least 6 years within Medical Affairs. * Demonstrated leadership in Medical Affairs Operations, strategic planning, portfolio management, or enterprise project management functions. * Proven success leading project managers, operational teams, and/or matrixed organizations. * Track record of supporting Medical Affairs strategy development and execution across multiple therapeutic areas, assets, and stages of the product lifecycle. * Strong understanding of Medical Affairs governance, operating models, and cross-functional collaboration within a matrix environment. * Knowledge of evidence generation activities, including investigator-sponsored studies (ISS), collaborative research, medical publications, and real-world evidence initiatives. * Solid understanding of clinical development processes and the role of Medical Affairs in lifecycle management, scientific engagement, and brand strategy. * Demonstrated ability to lead portfolio prioritization, resource planning, governance, and performance management processes. * History of effective partnership with Clinical Development, Regulatory Affairs, HEOR, Commercial, Legal, Compliance, and Finance functions to drive integrated planning and execution. * Familiarity with global and regional organizational structures, including alignment of regional priorities with global strategies, processes, and governance frameworks. Technical Skills & Competencies * Strong understanding of Medical Affairs operating models, governance structures, and the role of Medical Affairs across the product lifecycle. * Demonstrated expertise in strategic planning, portfolio management, resource planning, and organizational prioritization within a complex matrix environment. * Advanced knowledge of Medical Affairs planning and execution, including evidence generation, scientific communications, medical education, field medical, and investigator-sponsored research activities. * Strong understanding of clinical development, regulatory requirements, compliance standards, and industry guidelines relevant to Medical Affairs operations. * Proven ability to establish and optimize operational processes, governance frameworks, performance metrics, and business planning capabilities that drive organizational effectiveness and scalability. * Exceptional leadership and stakeholder management skills, with the ability to influence and align diverse cross-functional and global stakeholders without direct authority. * Strong business acumen and strategic thinking, with the ability to translate organizational priorities into actionable operational plans and measurable outcomes. * Excellent communication and presentation skills, with the ability to effectively engage senior leaders and facilitate decision-making across complex organizations. * Strong analytical and problem-solving capabilities, including the use of data and performance insights to support decision-making, resource allocation, and continuous improvement initiatives. * Proficiency with business planning, project portfolio management, reporting, and collaboration tools; advanced proficiency in Microsoft Office applications, including PowerPoint and Excel.   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 $300,000 to $330,000.  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. 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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.