Director, Quality - GCP (Contract)

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: The Associate Director, Clinical Quality Management serves as the central Risk-Based Quality Management (RBQM) Lead for Clinical Operations, responsible for enterprise-wide, proactive risk management across clinical trials. This role owns the end-to-end RBQM framework, including risk identification, assessment, mitigation, centralized monitoring, lessons learned, and maintenance of a clinical risk library, ensuring risks are managed consistently and intelligently across studies, programs, vendors, and regions. The role partners cross-functionally to embed risk-based decision-making into study design, execution, oversight, and continuous improvement, in alignment with ICH E6 (R3), GCP, and global regulatory expectations. Essential Functions: Risk-Based Quality Management (RBQM) Leadership •    Lead the design, implementation, and continuous evolution of a holistic RBQM framework across Clinical Operations, aligned with ICH E6 (R3) and regulatory guidance. •    Serve as the central RBQM authority ensuring consistent risk management approaches across trials, programs, regions, and vendors. •    Integrate RBQM principles into study planning, execution, oversight, and close-out activities. •    Provide expert oversight and guidance to study teams on study-level RBQM plans, ensuring alignment with enterprise risk strategy. Central Risk Identification, Monitoring & Mitigation •    Lead proactive, cross-study and cross-functional risk assessments to identify systemic, emerging, and study-specific risks. •    Define, standardize, and maintain Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) across trials. •    Oversee centralized risk monitoring and trending to enable early detection of critical risks. •    Partner with study teams to develop and oversee risk mitigation, contingency, and escalation plans, ensuring inspection Lessons  Learned & Risk Library Management (Core Ownership) •    Establish and maintain a centralized Clinical Risk Library, capturing: o    Known and emerging risks o    Root causes o    Mitigation strategies o    Effectiveness of controls •    Lead lessons learned activities across trials, audits, inspections, and CAPAs. •    Ensure lessons learned are: o    Systematically captured o    Analyzed for trends o    Fed back into RBQM planning, SOPs, training, and future studies •    Drive organizational learning by translating lessons learned into preventive, forward-looking risk controls.readiness. Quality Oversight & Regulatory Compliance •    Ensure clinical trial conduct complies with GCP, regulatory requirements, and company SOPs. •    Provide centralized quality oversight across trials, CROs, and vendors. •    Support audit and inspection readiness activities, including: o    Risk-based inspection preparation o    Impact assessments o    CAPA development and effectiveness checks Vendor & CRO Risk Oversight •    Design and implement risk-based oversight strategies for CROs and external vendors. •    Monitor vendor performance using quality metrics and risk indicators. •    Lead or support quality governance discussions with external partners. •    Ensure vendor-related risks are integrated into the central risk library and lessons learned framework. Data-Driven Quality & Continuous Improvement •    Leverage data analytics and centralized monitoring tools to enable real-time risk detection and decision-making. •    Generate enterprise-level risk trend reports and insights for senior leadership. •    Continuously refine RBQM methodologies based on data, inspection outcomes, and lessons learned. •    Champion a culture of proactive quality and continuous improvement across Clinical Operations. Cross-Functional Collaboration & RBQM Expertise •    Act as the RBQM Subject Matter Expert (SME) for Clinical Operations and Clinical Quality Compliance. •    Provide RBQM training and coaching to study teams and cross-functional stakeholders. •    Collaborate closely with Regulatory, Biostatistics, Data Science, QA, and Vendor Management teams to align risk strategies and metrics. •    Participate as an observing member on assigned study teams to provide real-time quality and risk support. SOP Management & Governance Support •    Partner with Document Control and SOP Administration teams to ensure RBQM and lessons learned are reflected in SOPs, WIs, and templates. •    Support governance activities, senior management reporting, and quality metrics standardization. •    Recommend and support implementation of corrective and preventive actions to protect system, process, and data integrity.provide real-time quality and risk support. Requirements: Education •    Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (required) •    Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (preferred) Experience •    10+ years of experience in Clinical Operations, Clinical Quality, RBQM, or RBM •    Demonstrated experience leading enterprise or cross-study risk management frameworks •    Strong background in audit/inspection readiness, CAPA management, and vendor oversight •    Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements Technical Skills •    Expertise with RBQM tools, centralized monitoring systems, and risk analytics •    Experience defining and using KRIs, QTLs, and quality metrics •    Familiarity with CTMS, eTMF, and data visualization tools (Spotfire, Tableau, Power BI) •    Exposure to AI or predictive analytics for quality monitoring (preferred) Working Conditions: Requires up to 25% domestic and international travel. May involve working outside of regular business hours to accommodate global time zones and project deadlines. The anticipated salary for this position will be $175,000 to $190,000.  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-TT1 #Hybrid #Princeton

Datadog

Datadog is seeking a Director, Technical Account Management (TAM) for the EMEA region to join our high-growth organization and world-class Technical Post Sales (TPS) Team. You will own the strategy, growth, and execution of a team of 25–30 today, with a clear mandate to scale to 50–70+ over the next two to three years. You will be building organizational infrastructure, developing first-line leaders, and establishing scalable processes before they're needed. TAMs are technical experts who provide paid "white glove" technical services to our largest customers, supporting adoption and providing guidance across the comprehensive Datadog product suite. A TAM is held in high regard as an expert and trusted advisor for how IT Operations translates to business value. This is a senior leadership role where you will set the technical post-sales vision for all of EMEA, own executive relationships with key accounts, evangelize the TPS offering at scale, and grow services revenue across the region. At Datadog, we place value in our office culture—the relationships and collaboration it builds and the creativity it brings to the table. We operate as a hybrid workplace to ensure our Datadogs can create a work-life harmony that best fits them. WHAT YOU'LL DO: * Scale the EMEA TAM organization from 25–30 to 50–70+, hiring first-line leaders, designing team structures, and building systems that sustain quality through rapid growth. * Lead a team of managers and senior TAM ICs across EMEA, ensuring customer success, retention, and expansion at high standards of technical delivery. * Own the commercial strategy for the TPS program, partnering with Sales to position, price, and sell TAM services as a core part of the Datadog value proposition. * Define and execute regional OKRs aligned with global TPS goals, driving accountability through your leadership team each quarter. * Lead executive-level recruiting and build a leadership pipeline from within, developing managers who can in turn scale their own teams. * Serve as executive sponsor for strategic EMEA accounts, engaging at the C-suite level to reinforce value, resolve escalations, and identify expansion opportunities. * Partner with global TPS, Product, Sales Engineering, CS, and Enablement to standardize and evolve the TAM offering, customizing for regional needs where warranted. * Establish operational rigor: clear metrics, health scorecards, capacity planning, and forecasting to give full visibility into team performance and customer outcomes. * Drive talent development programs such as performance reviews & career growth plans, focusing on building future leaders within the organization and motivating, growing, & retaining top talent.   WHO YOU ARE: * 8+ years leading Professional Services, TAM, or Sales Engineering teams, with demonstrated success scaling an organization from fewer than 25 to 50+ headcount. * Experience managing managers: you hire and develop first-line leaders and have a track record of building leadership depth within your orgs. * Commercially minded, with direct experience selling or co-selling services and a history of growing services revenue; you position TAM as a value driver, not a cost center. * Technically fluent across infrastructure, cloud platforms (AWS, Azure, GCP), observability, and monitoring, credible with practitioners and C-level executives alike. * A strategic operator who pairs vision with execution: you set direction, build the systems to support it, and develop your team's ability to operate independently. * 3–5+ years earlier in your career as a TAM, Solutions Architect, or equivalent client-facing technical IC, giving you firsthand credibility with your team. * Willing and able to travel up to 50% of the time across the EMEA region.   BONUS POINTS: * Experience redesigning organizational structures mid-growth: building new team shapes or specializations as a business scales. * Track record evangelizing cloud adoption, observability, or security to C-level and board-level stakeholders across EMEA. * Hands-on experience with Datadog or other leading cloud monitoring and observability platforms. * Multilingual or deep experience navigating multi-cultural teams across EMEA markets. Datadog values people from all walks of life. We understand not everyone will meet all the above qualifications on day one. That's okay. If you're passionate about technology and want to grow your skills, we encourage you to apply. BENEFITS AND GROWTH: * Best-in-breed onboarding * Generous global benefits * Intra-departmental mentor and buddy program for in-house networking * New hire stock equity (RSUs) and employee stock purchase plan (ESPP) * Continuous professional development, product training, and career pathing * An inclusive company culture, able to join our Community Guilds and Inclusion Talks Benefits and Growth listed above may vary based on the country of your employment and the nature of your employment with Datadog. ---------------------------------------------------------------------------------------------------------------------------------- About Datadog:  Datadog is the leading observability and security platform for the AI era, providing businesses with unified visibility across the technology stack to manage complexity at scale. It brings applications, infrastructure, data, models, and security into one place, using AI to detect and resolve issues before they impact customers. Trusted globally by Fortune 500 companies and high-growth AI leaders, Datadog enables businesses to move faster with clarity and confidence. Learn more about #DatadogLife on Instagram, LinkedIn, and Datadog Learning Center. ---------------------------------------------------------------------------------------------------------------------------------- Equal Opportunity at Datadog: Datadog is proud to offer equal employment opportunity to everyone regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, veteran status, and other characteristics protected by law. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Here are our Candidate Legal Notices for your reference.  Datadog endeavors to make our Careers Page accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please complete this form. This form is for accommodation requests only and cannot be used to inquire about the status of applications.  Privacy and AI Guidelines: Any information you submit to Datadog as part of your application will be processed in accordance with Datadog’s Applicant and Candidate Privacy Notice. For information on our AI policy, please visit Interviewing at Datadog AI Guidelines.

Baringa

ABOUT BARINGA  Baringa is a global consulting firm that partners with leaders to drive change and create value. With deep industry expertise, and enabled by advanced technology, the firm helps clients to deliver with greater confidence and certainty. With over 2,000 people across the UK, Europe, North America, Asia and Australia, the firm combines global insight with local understanding. The firm works across energy and resources, financial services, government and public sector, consumer products and retail, pharmaceuticals and life sciences, manufacturing, and technology, media and telecoms, with capabilities spanning strategy, transformation and operational excellence – all powered by advanced technology, data, AI and digital innovation. Clients value Baringa’s collaborative approach and the way its teams integrate seamlessly – all working with a shared understanding of what matters most. The firm is known for its kind, curious experts who listen closely and care deeply about client success as they help clients transform energy markets, modernise financial platforms, expand telecoms and digital networks through advanced data analytics, enable digital services in government, and unlock growth in consumer sectors. Certified as a Great Place to Work around the world, Baringa has been recognised by the Financial Times in 22 categories of its UK Leading Management Consultants rankings, and by Forbes for four consecutive years as one of the World’s Best Management Consulting Firms.   Our Solutions & AI Labs (SAIL) practice is looking for an experienced Senior Manager to lead consultancy engagements and grow our AI & Solutions Engineering capability. The Forward Deployed AI & Solutions Engineer role will lead the delivery of AI-enabled solutions embedded in our clients' teams, combining deep technical specialism with the commercial and leadership skills to grow and shape our practice.  This is a role for someone who thrives at the intersection of client advisory, technical architecture and hands-on delivery leadership – and who has a genuine passion for bringing AI solutions to production at scale.   Our Solutions & AI Labs (SAIL) practice focuses on helping clients control their data, turn it into actionable insights, and better leverage it through the use of AI and Machine Learning solutions directly embedded into business processes. We support clients across a number of industries and offer deep expertise in AI/ML, Cloud, Platform Engineering, and Managed Solutions.   What you will be doing  As a Senior Manager in SAIL, you will own and lead consultancy engagements end-to-end from shaping the opportunity and winning the work, through to delivery governance and team leadership. You will bring SME-level depth in at least one of AI/ML Engineering, Platform Engineering, or Software Engineering, and apply it to create real, lasting value for our clients.   Although we do not expect you to be an expert in all of the below activities simultaneously, our team consists of people who can work as advisors to our clients as well as bringing deep technical knowledge when needed. The profile of our typical engagements reflects that.   Key responsibilities span the following areas.   Engagement Leadership:  * Own and lead end-to-end delivery of complex AI and technology consulting engagements, taking accountability for scope, quality, risk and client outcomes.  * Lead and resource multi-disciplinary delivery teams including engineers, data scientists and consultants providing clear direction, technical oversight and people development.  * Manage engagement resourcing: forecast team requirements, work with practice leadership to staff engagements, and develop the talent pipeline through mentoring and support of junior practitioners.  * Proactively identify and manage delivery risks in complex stakeholder environments, escalating appropriately and maintaining client confidence throughout.  * Communicate clearly to both technical teams and senior client stakeholders, translating complexity into actionable insight and decisive recommendation.  * Conduct rigorous technical reviews and uphold engineering and delivery standards across every engagement you lead.   Business Development & Bid Support:  * Play a leading role in business development: identifying new opportunities, shaping propositions, and supporting or leading bids and tender responses for AI and technology engagements.  * Contribute to proposal writing, articulating Baringa’s capabilities and differentiators, including authoring technical and delivery sections of bid responses to client tenders and RFPs.  * Build and maintain strong client relationships, acting as a trusted advisor and developing opportunities for follow-on engagement.  * Support practice-level growth initiatives, including account planning, capability development, and go-to-market positioning for AI and solutions engineering services.   Technical Architecture & Delivery:  * Lead architecture design for AI-enabled platforms and cloud solutions, balancing technical excellence with delivery pragmatism and commercial realities.  * Provide hands-on technical direction where required – reviewing designs, code and delivery artefacts to maintain quality standards across the engagement.  * Champion the path from prototype to production: driving robust, scalable and secure AI deployments that go beyond proof-of-concept thinking to real business impact at scale.  * Act as a credible technical voice with client architects, CTOs and engineering leads, earning trust through depth of knowledge and a demonstrable delivery track record.  AI/ML Specialism  You will bring expert-level knowledge in at least one of the following domains, and working knowledge across the others:   Agentic AI & LLM Engineering:  * Design and build production-grade agentic systems using major LLM SDKs and agent frameworks; deep knowledge of RAG, MCP servers and prompt engineering at scale.  * Strong opinions on secure, resilient enterprise deployment of LLM-powered systems; current knowledge of the latest model capabilities and AI product stacks.   Machine Learning Engineering:  * End-to-end ML lifecycle expertise: feature engineering, model training, evaluation and production deployment, including MLOps, monitoring and drift detection.  * Practical knowledge of ML frameworks (e.g. scikit-learn, PyTorch, XGBoost) and cloud-native ML services (SageMaker, Azure ML, Vertex AI).  Platform & Cloud Engineering:  * Architecture and delivery of scalable cloud data and AI platforms on AWS, Azure or GCP; experienced with containerisation, IaC, event-driven architectures and CI/CD.  * Track record of delivering production Python services and APIs; working knowledge of cloud-native application patterns and release practices.   Software Engineering:  * Production-grade Python services (FastAPI, AWS Lambda, event-driven patterns) and front-end development with React/Next.js, Material UI and SWR.  * Cloud architecture design capability across major providers; rounded understanding of database trade-offs – relational, NoSQL, graph and caching strategies.  * Strong engineering practices: CI/CD, testing (Jest, Cypress, React Test Library), release management and security-conscious development.   * A genuine passion for AI solutions and specifically for the complexity of delivering them to production at scale. You should be as energised by the hard problems of operationalisation, reliability and governance as by the technology itself.   Your Skills and Experience   We're seeking a technically credible, commercially aware leader who brings a rare combination of delivery accountability, client advisory skill, and deep AI/technology specialism. You will be someone energised by the complexity of taking AI solutions to production at scale – and who can inspire a team and a client with that same passion.  * 7+ years in technology consulting, software engineering or AI/ML, with at least 3 years in a senior leadership role – including direct accountability for end-to-end engagement delivery, resourcing and commercial outcomes.  * Experience supporting or leading bid and proposal activity, including writing technical and delivery sections of responses to client tenders and RFPs.  * SME-level depth in at least one of: Agentic AI/LLM Engineering, Machine Learning Engineering, Platform & Cloud Engineering, or Software Engineering – with strong architecture and design capability across cloud, data and AI domains.  * Proven ability to build and lead high-performing delivery teams in complex stakeholder environments, with experience engaging comfortably at CTO or engineering director level.  * Clear, confident communicator – able to make the complex accessible for technical and non-technical audiences alike, and to represent Baringa’s expertise with credibility.  * Master’s degree in Computer Science, Engineering, Mathematics, Data Science or related discipline, or equivalent depth through relevant professional certifications (e.g. AWS Solutions Architect Professional, Google Professional ML Engineer).  * Desirable: prior experience as a forward-deployed or embedded engineer within a client environment; exposure to regulated industries such as energy, financial services or public sector.  If you are excited by the opportunity to lead meaningful AI and technology engagements for major clients and thrive in a collaborative, people-first culture that values both technical rigour and human connection we would love to hear from you.  JOIN US All applications received will be reviewed by a member of our Talent Acquisition team. We never rely solely on automated screening or AI tools to make hiring decisions. Your application will be considered for employment without regard to race, ethnicity, religion, gender, gender identity or expression, sexual orientation, nationality, disability, age, faith or social background. We do not filter applications by university background and encourage those who have taken alternative educational and career paths to apply. We would like to actively encourage applications from those who identify with less represented and minority groups. We operate an inclusive recruitment process, ensuring reasonable adjustments where needed. Please contact a member of our Recruitment Team to discuss further.   BARINGA PRIVACY NOTICES For UK & EU Your personal data will be retained by Baringa for up to two years, in accordance with our UK Recruitment Privacy Notice / EU Recruitment Privacy Notice, to evaluate your application and meet our legal and reporting obligations. In line with the General Data Protection Regulation (GDPR), you have the right to request access to, rectification, or erasure (subject to legal limitations) of your personal data. For more information, please contact us at privacy@baringa.com For the USA Your personal data may be retained by Baringa for up to two years, as outlined in our Recruitment Privacy Notice (AMER & APAC), to support the recruitment process and internal reporting requirements. Where applicable, and in accordance with relevant federal and state laws, you may have the right to request access to or correction of your personal information. For further details, please contact privacy@baringa.com For Australia & Singapore Your personal data will be retained by Baringa for up to two years, in accordance with our Recruitment Privacy Notice (AMER & APAC), to assess your application and meet applicable reporting and legal obligations. In line with the Australian Privacy Act and Singapore’s Personal Data Protection Act (PDPA), you may have rights to access, correct, or request limited deletion of your personal data. For more information, please contact us at privacy@baringa.com