Senior Manager, Quality Control

Senior Manager, Quality Control Responsibilities

• Manage QC Chemistry or Microbiology laboratory operations; ensure GMP, protocol, and safety compliance.
• Manage QC personnel: organize/prioritize daily tasks, training, and performance reviews.
• Oversee day-to-day laboratory operations.
• Write/implement changes to controlled documents (SOPs, software specifications, methods).
• Follow technology changes; recommend and implement new technologies as appropriate.
• Lead/coordinate projects, initiatives, and investigations; solve complex issues with in-depth assessment.
• Select appropriate analytical methods/techniques/evaluation criteria using sound judgment.
• Provide QC Chemistry/Microbiology expertise and counsel.
• Lead training and career coaching for QC staff and manage Team Leaders, Chemists, Microbiologists, and Technicians.
• Perform data review, process trending, procedural updates, and support qualification protocol writing.
• Interact with senior management/executives; participate in regulatory audits as required.
• Direct team activities to meet schedule, budget, and resource requirements.

• Excellent communication/interpersonal skills; effective teamwork.
• Critical/creative thinking; independent problem-solving; strong organizational/planning skills.
• In-depth GMP, pharmacopoeia, and regulatory knowledge for pharmaceutical testing/validation.
• Proven leadership and problem-solving; current industry knowledge; strong analytical and computer skills.
• Education/
  
  Experience:
  
  8+ years + BS; or 6+ years + MS; or 2+ years + PhD; QC experience in a highly regulated manufacturing environment.
• Preferred: prior people management; biopharmaceutical/pharmaceutical experience.

• Salary range: $–$. May be eligible for discretionary bonus/long-term incentives, paid time off, and company-sponsored medical, dental, vision, and life insurance.