Provide independent QA review and approval of policies, procedures and QC-generated documents, including test methods, specifications, protocols and reports (validation, qualification, transfer), stability documentation, analytical comparability studies.
Perform QA data verification for release and stability testing ensuring technical review is completed by QC prior to QA compliance review.
Support and/or approve lot disposition decisions based on QC data package
Provide QA oversight of method validation, method verification, method transfer (internal and external CTLs), method finalization and implementation
Confirm alignment between approved specifications and validated methods.
Own QA oversight of QC-related systems, including change controls, deviations and OOS/OOT/OOE investigations, CAPAs and risk assessments.
Ensure timely and thorough investigations with appropriate root cause analysis.
Ensure appropriate impact assessments (quality, regulatory, product).
Partner with QC leadership to drive continuous improvement.
Ensure ALCOA+ principles are consistently applied within QC.
Support inspection readiness and participate in regulatory inspections and audits as necessary.
Partner closely with QC, Regulatory Affairs, External Manufacturing, Process Development, Supply Chain

13+ years of experience in QA and/or QC within biotechnology or pharmaceutical industry.
Strong, demonstrated experience with Analytical method validation, QC data review, OOS investigations, cGMP laboratory operations
Experience supporting Contract Manufacturing Organizations and Contract Testing Laboratories.
Strong technical understanding of analytical testing
Independent decision-making ability
Risk-based thinking
Inspection readiness mindset
Excellent written and verbal communication skills
Ability to lead without direct authority

Associate Director, QA-QC Operations

Key skills