Quality Control Manager

Quality Control Manager

Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.

Our client is seeking a Quality Control (QC) Manager to lead both Microbiology and Analytical Quality Control functions at a CDMO manufacturing site. This role is responsible for ensuring compliant, high-quality testing to support clinical and commercial manufacturing. This is a contract role - estimated to be for 6 months. Client is based in the Greenville, NC area. This is an onsite opportunity. Local candidates preferred.

In this role, you will oversee laboratory operations, manage a team of analysts, and partner closely with Manufacturing and Quality to ensure timely and accurate release of materials and products.

Title: Quality Control Manager

Responsibilities Include:

• Lead QC Microbiology and Analytical teams, including hiring, development, and performance management
• Ensure all laboratory testing activities comply with cGMP and regulatory requirements (FDA, EMA)
• Oversee microbiological testing activities (EM, sterility, endotoxin, bioburden) and analytical testing (release/stability)
• Manage laboratory operations to ensure timely testing execution and batch disposition support
• Review and approve laboratory data, investigations, deviations, and OOS/OOT results
• Drive CAPA, change control, and continuous improvement activities across the QC operation
• Support regulatory inspections, client audits, and responses
• Ensure proper maintenance, qualification, and calibration of laboratory equipment
• Collaborate cross-functionally with Manufacturing, QA, and clients to support production and quality objectives
• Support method transfer, method validation, and new product introductions
• Monitor laboratory KPIs and identify opportunities to improve throughput and efficiency

Experience/Education:

• Bachelor's degree in Chemistry, Microbiology, or related scientific field
• 7+ years of QC experience in pharma, biotech, or CDMO environments
• Hands-on experience in both microbiology and analytical testing required
• Proven leadership experience managing laboratory teams
• Strong knowledge of cGMP and FDA/EMA requirements
• Experience supporting audits and inspections
• Strong experience with investigations, OOS/OOT management, deviations, CAPAs, and change controls
• Excellent communication and cross-functional collaboration skills

Preferred Qualifications:

• Experience supporting sterile manufacturing and aseptic processing operations
• Experience within CDMO or multi-client manufacturing environments
• Experience supporting remediation or inspection-readiness initiatives
• Familiarity with LIMS and laboratory systems management
• Prior experience at the Manager or Senior Manager level overseeing both Microbiology and Analytical QC functions

Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.