Senior Manager, Product Development Quality Assurance (CMC Product Lead)
Core
Ensuring high-quality clinical supplies compliant with global regulatory requirements are delivered to patients by overseeing the supply chain from drug substance to finished product.
Role type
Senior Manager, Clinical Product Supply (Quality Assurance)
Builds
Clinical trial supplies and finished pharmaceutical products
Domain
Pharmaceutical manufacturing and Quality Assurance (GMP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical manufacturing process knowledge, analytical sciences, global GMP requirements (D, EU, US), risk-based problem solving, regulatory inspection support, contract quality agreement management, cross-functional consensus building, staff mentorship
Preferred skills
Project management, in-licensing collaboration, investigational product experience, PMP certification
Technologies
GMP compliance frameworks, quality management systems
Responsibilities
Provide program oversight for the RDQA QA organization; Serve as QA representative for CMC product development teams to facilitate drug approval for clinical trials; Lead complex global cross-functional process improvement teams; Support preparation for regulatory inspections and internal audits; Manage clinical supply product actions and recalls; Ensure suitable quality agreements with third-party manufacturers and laboratories
Seniority
Senior Manager, strategic oversight and team leadership