Senior Manager Quality Control Investigations

Position Summary

Provide Quality Control (QC) leadership and ownership for site investigations and CAPA execution related to QC operations and laboratory activities. This role is accountable for ensuring investigations are scientifically sound, timely, and compliant, while partnering closely with Quality Assurance for independent oversight and regulatory alignment.

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.

Reporting Relationship

Acts independently to determine methods and procedures for investigation execution within Quality Control. Receives assignments in the form of objectives and establishes goals to meet investigation, compliance, and performance expectations. Work is reviewed and measured based on meeting established objectives, investigation timeliness, quality, and compliance metrics. Identifies and escalates risks, trends, and deviations from standard practices to senior management, recommending and implementing corrective and preventive actions.

Independent Contributor

Independent contributor with site-level influence across QC functions.