Job title: Head of R&D Quality
Main ResponsibilitiesOrganizational Leadership & Transformation
- Lead the design, build-out, and operationalization of a centralized R&D Quality organization, establishing a unified R&D OneQuality operating model
- Drive cultural and operational transformation to build a high-performance, collaborative, compliance-focused organization
- Serve as the single accountable leader for quality across the full R&D lifecycle from early research through regulatory submission and post-approval activities
- Develop and execute the enterprise quality strategy aligned with corporate objectives
- Drive digital transformation and AI-enabled quality processes
Functional Quality Oversight
Provide strategic direction and oversight to dedicated functional quality teams including:
- Clinical Quality: GCP compliance, clinical trial quality oversight
- Pharmacovigilance (PV) Quality: GVP compliance, safety data quality
- Medical Quality: RWE, PASS studies, Post Trial Access, IVDR compliance
- Regulatory Quality: Regulatory submission quality and compliance
- Ensure deep GxP expertise is maintained within each functional domain while enabling cross-functional collaboration and business partnering
Transversal Quality Capabilities
Build and lead standardized, scalable transversal quality frameworks including:
- Quality Documentation & Training Compliance: Harmonized documentation standards and training frameworks across R&D
- Vendor Quality Oversight: End-to-end vendor qualification, monitoring, and performance management
- Audits & Inspection Management: Coordinated audit planning, inspection readiness, and regulatory agency interaction
- R&D Quality Transversal Operations: Performance metrics, cross-functional change controls, data quality, and dynamic resource allocation
- Drive standardization of processes, tools, and ways of working to eliminate duplication and variability across R&D functions
Strategic Partnership & Governance
- Act as the OneQuality voice for R&D; a trusted, embedded strategic business partner enabling innovation through quality excellence
- Partner closely with R&D leadership, the CMO office, and cross-functional stakeholders (Regulatory, Clinical, Medical, M&S) to align quality strategy with R&D priorities
- Represent R&D Quality in senior governance forums, Works Councils, and regulatory agency interactions
- Establish clear decision rights, governance structures, and escalation pathways across the new organization
Risk, Compliance & Performance
- Ensure comprehensive, proactive quality coverage across all R&D deliverables, including but not limited to RWE & PASS studies, Post Trial Access, Research activities, and IVDR compliance
- Implement integrated risk management frameworks and quality alert systems to identify and mitigate compliance risks early
- Define and monitor KPIs to drive continuous improvement and operational excellence
- Oversee deviation & CAPA management, change control, and risk management processes across R&D
About YouExperience & Background
- 15+ years of progressive experience in pharmaceutical R&D Quality, with a strong track record in GxP-regulated environments (GCP, GVP, GLP, and/or GMP)
- Demonstrated experience leading large, complex quality organizations (100+ FTEs) across multiple functions or geographies
- Proven track record in organizational transformation; designing and implementing new operating models, driving change management, and building high-performing teams
- Deep knowledge of the R&D lifecycle from early research through post-approval, with familiarity across clinical, pharmacovigilance, medical, and regulatory quality domains
- Experience managing regulatory agency inspections (FDA, EMA, and other health authorities) and representing quality in high-stakes regulatory interactions
Leadership & Interpersonal Skills
- Exceptional executive presence with the ability to influence and engage at C-sui
- Strong people leadership skills; able to inspire, develop, and retain diverse, geographically distributed teams
- Collaborative and strategic mindset; able to balance the role of quality guardian with that of an enabling business partner
- Demonstrated ability to lead through ambiguity and drive alignment across complex, matrixed organizations
- Strong communication skills, with the ability to translate complex quality and compliance topics for non-specialist audiences
Technical Competencies
- Comprehensive knowledge of GxP regulations (GCP, GVP, GLP/GcLP) and international regulatory frameworks
- Familiarity with IVDR and evolving regulatory requirements in real-world evidence and post-approval settings
- Experience with quality management systems, audit and inspection management, vendor oversight, and documentation/training compliance
- Data-driven approach to quality, comfortable with metrics, dashboards, and performance management frameworks
Why Choose Us- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.
The salary range for this position is:
$293,250.00 - $423,583.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
