Site Head of Quality
About The Position
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 Site Head of Quality to lead all Quality functions at the CDMO manufacturing site in Greenville, North Carolina. This is a contract role – estimated to be for 6 months. This is an onsite opportunity. Local candidates preferred. This role is responsible for ensuring compliance with global regulatory requirements, maintaining a robust quality system, and supporting the successful execution of commercial and clinical manufacturing operations. The ideal candidate will bring deep expertise in sterile manufacturing / aseptic fill-finish operations and a proven track record in regulatory compliance and inspection readiness. The Site Head of Quality will serve as a key member of the site leadership team, partnering closely with Manufacturing, Technical Operations, and clients to drive quality performance and continuous improvement.
Requirements
- Bachelor’s degree in a scientific discipline (advanced degree preferred)
- 15+ years of Quality leadership experience within pharmaceutical, biotech, or CDMO environments
- Strong experience in sterile manufacturing / aseptic fill-finish operations required
- Proven leadership experience managing QA/QC teams
- Deep knowledge of cGMP, FDA, EMA, and global regulatory requirements
- Demonstrated success leading regulatory inspections (FDA/EMA) and maintaining strong compliance performance
- Experience in a CDMO or multi-client environment strongly preferred
- Strong understanding of commercial and clinical manufacturing operations
- Excellent leadership, communication, and problem-solving skills
- Ability to operate strategically while managing day-to-day quality execution
Nice To Haves
- Prior experience serving as Site Head of Quality or Quality Director within a CDMO environment
- Experience supporting multi-client manufacturing operations
- Experience leading organizations through regulatory initiatives
- Strong background in aseptic processing and sterile manufacturing quality systems
Responsibilities
- Lead all site Quality functions, including Quality Assurance, Quality Control, Quality Systems, and Compliance
- Ensure ongoing compliance with FDA, EMA, and global regulatory requirements (cGMP), with a focus on sterile/aseptic operations
- Own and maintain the site Quality Management System (QMS)
- Lead regulatory inspections, client audits, and responses with a strong compliance-first approach
- Partner with clients to meet quality expectations and ensure successful program delivery
- Provide operational oversight of deviation, CAPA, change control, and risk management processes
- Ensure compliant and timely batch disposition and product release
- Drive continuous improvement in quality systems, processes, and performance
- Build, lead, and develop a high-performing Quality organization
- Collaborate cross-functionally with Manufacturing, Supply Chain, Validation, Regulatory, and Technical Operations
- Support new product introductions, tech transfers, and commercial readiness
- Monitor and report key quality metrics and drive a state of continuous inspection readiness
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What This Job Offers
Job Type
Full-time
Career Level
Senior
