QC Manager

Essential Duties & Responsibilities:

• Manages the QC Microbiology testing programs and personnel.   
• Manages day to day operations and weekly testing schedule.
• Works with Product Development (PD) for the timely completion of required PD sample testing.
• Reviews and approves QC testing forms.
• Responsible for changing the status of appropriate Class I raw materials in SAGE and miscellaneous issuing of raw materials for testing.
• Subject matter expert of relevant QC Microbiology assays.
• Qualified to perform all QC assays and help with trouble shooting as required.
• Responsible for overall cGMP compliance of the department and may represent QC on project teams or during external audits and inspections.   
• Must have experience in writing technical documents and protocols.
• Able to clearly communicate problems and observations with management from other departments.
• Deliver to Plan: Lead and direct the safety, quality, and daily operation in QC. Oversee all tasks in the lab and clean rooms as they are carried out.
• Maintain a good working relation with other departments.
• Monitor and coach staff to ensure full compliance with GMP and Quality system requirements. Responsible for overall inspection readiness and compliance with quality requirements.
• Lead and oversee the on-time completion of document review for completeness, clarity, accuracy to support on-time release of clinical lots.
• Adapts departmental plans and priorities to address resource and operational challenges.
• Excellent verbal and written communication skills.
• Ensure that the quality control labs are well maintained and inspection ready at all times.
• Coach, teach, train, and develop employees through 1:1 meetings.
• Maintain individual training plan and ensure team remains up to date with training readiness. Strong business acumen to manage diverse teams.
• Perform other duties as assigned. 

Minimum Qualifications:

• Education/Training:
  • BS in Microbiology, Biology, or equivalent
  • Preferred area of study:  Science related discipline

• Experience:
  • 7-10 years’ experience in a relevant field. Experience in a GMP setting and previous supervisory experience preferred. 

• Knowledge:
  • Strong knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics and cell and gene therapy products.
  • Strong knowledge of current industry trends and can use the latest technologies. 

• Skills:
  • Subject matter expert in quality control microbiology assays including sterility testing and endotoxin. 
  • Must have a thorough knowledge of cGMP facilities and cGMP requirements. 
  • Computer software skills, organization, record keeping and planning skills, budget preparation, training skills, multiple projects, time management, facilitation skills are a plus. 
  • Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines. 
  • Ability to exercise judgment within defined procedures and practices to determine appropriate action.  
  • Assure pragmatic problem solving is carried out with a strong sense of purpose and urgency and notify/make recommendations to Management regarding serious compliance or quality issues.
  • Proven logic and decision-making abilities, critical thinking skills. Aseptic practices and clean room operations.