Sr. QC Manager, Microbiology and Sterility Assurance
Position Overview: In this role, you will manage and oversee the operations of the microbiology quality control lab, focusing on monitoring critical environmental factors, performing sterility evaluations, and executing specialized microbiological tests. Your responsibilities will include ensuring compliance with industry standards, managing lab operations, coordinating with cross-functional teams, and overseeing the validation of new methods and equipment. You will also manage relationships with external laboratories and plan for future lab enhancements.
Essential Qualifications:
- Degree in Biological Sciences or a related field.
- Proven experience in managing pharmaceutical laboratory operations and regulatory interactions.
- At least 10 years of experience in regulated lab environments or pharmaceutical production.
- Comprehensive understanding of industry standards and regulations, including cGMP, FDA, and international guidelines.
Desirable Qualifications:
- Bachelors Degree in Microbiology or similar field
Key Responsibilities:
- Lead and develop a team of QC Microbiology professionals, including hiring, training, and performance management.
- Develop and implement resource plans for personnel, facilities, and equipment to meet operational demands.
- Enhance lab compliance, efficiency, and service quality through active management and continuous improvement.
- Collaborate with project teams to deliver timely lab support and identify future needs for technology and staffing.
- Oversee investigations into lab and environmental issues, ensuring effective corrective and preventive measures are taken.
- Evaluate the impact of microorganisms on processes and the effectiveness of contamination control measures.
- Manage lab method development, validation activities, and vendor audits to ensure quality and compliance.
- Review and assess new projects to ensure the lab is equipped to support future business growth.
