Senior Manager, Clinical Product Supply Quality (all genders) (full-time, regular)
Core
Provide strategic QA oversight for clinical development programs, managing risk, supply continuity, and regulatory compliance for investigational products.
Role type
Senior Manager, Clinical Product Supply Quality
Builds
Clinical supply quality strategies, risk mitigation plans, and compliant product release for global clinical trials.
Domain
Pharmaceutical manufacturing and clinical supply chain
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic QA oversight, risk management, GMP compliance, due diligence, cross-functional leadership, issue management, regulatory inspection readiness, quality agreements, project management
Preferred skills
Master's degree in life sciences, PMP certification, M&A integration experience
Technologies
GMP, CMC, OOS/OOT, quality agreements
Responsibilities
Provide strategic QA oversight for assigned clinical development programs; Lead identification and mitigation of quality and supply risks across the product lifecycle; Lead or oversee quality assessments supporting due diligence activities; Collaborate with partners to ensure appropriate quality agreements are established; Lead complex, global, cross-functional process improvement initiatives; Provide oversight and direction for complex investigations and product quality actions.
Seniority
Senior Manager, strategic leadership
