Manager, QA Validation Oversight
Core
Lead a team ensuring the integrity of process validation processes, supporting the transition from development to manufacturing, and ensuring global consistency and regulatory compliance.
Role type
Manager, QA Validation Oversight
Builds
Process validation strategies, documentation, and regulatory compliance for biopharmaceutical manufacturing.
Domain
Biopharmaceuticals / Process Validation / GMP
Deliverable
client delivery
Required skills
Process validation expertise, GMP-regulated environment experience, team leadership, regulatory inspection defense, change control management, failure investigation oversight, SOP management, validation master plan oversight.
Preferred skills
Continuous improvement mindset, cross-functional collaboration, professional development coaching.
Technologies
None stated
Responsibilities
Ensure alignment between validation activities and Process Sciences initiatives; Collaborate with Process Sciences team to ensure consistency in validation strategies; Present and defend validation strategies to FDA and regulatory agencies; Review and approve process validation documents and protocols; Oversee QA Validation aspects including failure investigations and change controls; Conduct performance reviews and set development goals for team members.
Seniority
Manager, hands-on IC with team leadership
