Manager, Quality Control

Manager, Quality Control (QC) responsibilities:

• Manage QC personnel: organize/prioritize daily tasks, perform training, and write performance reviews.
• Oversee day-to-day laboratory operations.
• Attend project team meetings and address assigned items.
• Write/implement changes to controlled documents (SOPs, software specifications, methods, etc.).
• Follow technology changes; recommend and implement new technologies when appropriate.
• Lead/co-ordinate projects/initiatives and investigations requiring in-depth assessment and judgment.
• Select methods/techniques/evaluation criteria to obtain analytical results; exercise judgment within defined practices/policies.
• Provide broad-based QC Chemistry or Microbiology expertise and counsel.
• Provide leadership, management, training, and career coaching for QC staff.
• Perform data review, process trending, procedural updates; support qualification protocol writing.
• Manage/guidance/training for QC Team Leaders, Chemists, Microbiologists, and Technicians.
• Interact with senior management/executives across functional areas/divisions/customers.
• Participate in regulatory audits as required.
• Direct team activities to meet schedule, budget, and resource requirements.

• Excellent communication and interpersonal skills; effective teamwork.
• Critical/creative thinking; independent work; strong organization and planning.
• In-depth GMP, pharmacopoeia, and regulatory requirements knowledge for pharmaceutical testing/validation.
• Proven leadership and problem-solving skills; knowledge of industry trends/conventions.
• Excellent analytical and computer skills.

• 6+ years relevant industry experience with a BS; or 4+ years with an MS; or 0+ years with a PhD.
• Experience/knowledge of quality control in a highly regulated manufacturing environment.

• Prior people management experience.
• Biopharmaceutical or Pharmaceutical experience (plus).