Site Head of Quality

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.Title: Site Interim Head of QualityRole: 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.Responsibilities Include:Lead all site Quality functions, including Quality Assurance, Quality Control, Quality Systems, and ComplianceEnsure ongoing compliance with FDA, EMA, and global regulatory requirements (cGMP), with a focus on sterile/aseptic operationsOwn and maintain the site Quality Management System (QMS)Lead regulatory inspections, client audits, and responses with a strong compliance-first approachPartner with clients to meet quality expectations and ensure successful program deliveryProvide operational oversight of deviation, CAPA, change control, and risk management processesEnsure compliant and timely batch disposition and product releaseDrive continuous improvement in quality systems, processes, and performanceBuild, lead, and develop a high-performing Quality organizationCollaborate cross-functionally with Manufacturing, Supply Chain, Validation, Regulatory, and Technical OperationsSupport new product introductions, tech transfers, and commercial readinessMonitor and report key quality metrics and drive a state of continuous inspection readinessEducation/Experience:Bachelor's degree in a scientific discipline (advanced degree preferred)15+ years of Quality leadership experience within pharmaceutical, biotech, or CDMO environmentsStrong experience in sterile manufacturing / aseptic fill-finish operations requiredProven leadership experience managing QA/QC teamsDeep knowledge of cGMP, FDA, EMA, and global regulatory requirementsDemonstrated success leading regulatory inspections (FDA/EMA) and maintaining strong compliance performanceExperience in a CDMO or multi-client environment strongly preferredStrong understanding of commercial and clinical manufacturing operationsExcellent leadership, communication, and problem-solving skillsAbility to operate strategically while managing day-to-day quality executionPreferred Qualifications:Prior experience serving as Site Head of Quality or Quality Director within a CDMO environmentExperience supporting multi-client manufacturing operationsExperience leading organizations through regulatory initiativesStrong background in aseptic processing and sterile manufacturing quality systemsTunnell 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.