Senior Manager Quality Control Investigations

Duties / Responsibilities

• Lead and manage the deviation and investigation process for Quality Control operations, including analytical testing, microbiology, bioassay, environmental monitoring, and laboratory systems.
• Serve as the QC subject matter expert (SME) for root cause analysis, CAPA development, and effectiveness verification related to laboratory and testing-related events.
• Ensure investigations are data-driven, scientifically rigorous, and supported by appropriate laboratory evidence, trending, and risk assessment.
• Partner with Quality Assurance, Manufacturing, MSAT, Engineering, and Regulatory to ensure investigations meet regulatory expectations while accurately reflecting QC process and laboratory realities.
• Support internal audits and regulatory inspections by providing QC investigation expertise, documentation, and direct engagement with inspectors as needed.
• Develop, standardize, and deliver training for QC personnel on investigation best practices, data integrity, and compliance expectations.
• Drive continuous improvement initiatives within QC to strengthen investigation quality, documentation consistency, and inspection readiness.
• Ensure QC investigation activities comply with applicable global regulations (FDA, EMA, ICH) and internal quality standards.

Qualifications

• Bachelor’s degree in Life Sciences, Biotechnology, Chemistry, Microbiology, or a related scientific discipline.
• 5–8 years of experience in Quality Control and/or GMP laboratory operations within the biotech or pharmaceutical industry.
• Demonstrated expertise leading laboratory investigations, root cause analysis, and CAPA management in a regulated environment.
• Strong working knowledge of cGMP regulations, ICH guidelines, data integrity principles, and laboratory quality systems.
• Experience with electronic quality systems (e.g., Veeva, TrackWise, SAP) and laboratory informatics (e.g., LIMS) preferred.