Associate Director, GMP Operational Quality (Biologics and Devices)
Core
Strategic and operational Quality oversight for drug substance disposition from development through process performance qualification, ensuring alignment with patient safety and regulatory expectations.
Role type
Senior IC GMP Quality Assurance Leader
Builds
External drug substance manufacturing operations and quality systems
Domain
Biologics pharmaceutical manufacturing
Required skills
cGMP principles, cross-functional leadership, Quality Agreements negotiation, change control management, deviation investigation, CAPA implementation, risk-based decision-making, regulatory submission review, audit support, electronic document management systems
Preferred skills
Mentoring and coaching, strategic quality planning, continuous improvement, stakeholder alignment
Technologies
QDocs, TrackWise, Veeva
Responsibilities
Lead cross-functional collaboration to resolve complex deviations; Represent Quality on cross-functional teams as a senior technical resource; Lead drafting and oversight of Quality Agreements with CDMOs and suppliers; Provide Quality leadership for change controls and deviation investigations; Review and approve batch records and regulatory submissions; Drive Quality readiness for major development milestones including IND/IMPD submissions and PPQ.
Seniority
Senior, hands-on IC with leadership responsibilities