Associate Director, QA-QC Operations (Contract)

What You'll Do:

• 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

About You:

• 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