QC Manager

About the role

QC Manager – Raw Materials provides strategic leadership and operational oversight for the Raw Material Release team within Quality Control. Working closely with the Head of Quality Control, this role supports departmental strategy, business objectives, and key performance indicators. The manager oversees analytical testing resources to ensure timely, accurate, and compliant release of raw materials and in‑process samples for GMP products, mentors laboratory personnel, and serves as a key liaison across Quality, Manufacturing, Supply Chain, and other business functions.

Responsibilities

• Leadership and Team Development: Establish strategic direction for raw material testing, build strong cross‑functional partnerships, drive a culture of accountability, urgency, compliance, and continuous improvement; set performance expectations; lead team planning, prioritization, workload balancing, and resource allocation; coach, mentor, and develop QC Analysts; align quality objectives with site business goals and customer requirements.
• Laboratory Asset Management: Ensure GMP and data‑integrity compliance; conduct routine safety audits; review performance metrics and trends; improve maintenance and operation of analytical equipment; approve quality‑impact assessments for equipment qualifications; oversee calibration, preventive maintenance, work‑order activities, and equipment readiness; partner with QA and Engineering to keep equipment qualified.
• QC Investigations Management: Create and approve investigational testing plans for OOS, OOT, analytical deviations, data‑integrity investigations, and CAPAs; ensure root‑cause identification, product impact assessment, and effective corrective actions; collaborate with QA leadership to improve investigation cycle times, compliance performance, repeat OOS review, and right‑first‑time performance.
• Regulatory Compliance Support: Support regulatory inspections and customer audits of the QC laboratory; act as subject‑matter expert for laboratory compliance; stay current with regulations and industry standards for analytical testing.

Requirements

• Bachelor's, master's, or doctoral degree in Chemistry, Engineering, or a related discipline.
• Eight or more years of experience in a pharmaceutical or biotechnology analytical laboratory.

Skills

• Demonstrated knowledge of analytical equipment, processes, and practices.
• Strong attention to detail, integrity, and reliability.
• Proficiency with Microsoft Word, Excel, Outlook, and PowerPoint.
• Project management, organization, technical writing, and presentation skills.
• Technical problem‑solving proficiency and ability to troubleshoot time‑sensitive challenges.
• Knowledge of and experience with safety and environmental compliance regulations.
• Excellent leadership and team‑development abilities.
• Excellent verbal and written communication skills.
• Ability to contribute actively to improvements in policies, practices, and procedures.
• Effective interaction and communication with customers and employees at all levels, including senior management.

Benefits

• Competitive salary and benefits package.
• Excellent Medical, Dental, and Vision coverage, available immediately.
• Generous PTO.
• 401K match.
• Wellness reimbursement.
• Parental leave.
• Career development opportunities.
• Company‑paid and voluntary Life and AD&D insurance.
• Short‑ and long‑term disability coverage.
• Paid holidays.