Associate Director/Director, Quality Control (QC).

We use science to save lives, and so can you . We are currently recruiting for an Associate Director or Director of QC to head up the team. The role manages and directs all activities of Quality Control staff and contractors, including but not limited to GMP release and stability testing, routine environmental, utility, and process monitoring capabilities for gene therapy products, management of raw materials, sample management, equipment calibration and maintenance, and contract lab testing oversight. The role is onsite, based out of our Bedford, MA facility and reports to the US Head of Quality and is a key part of the US Quality Leadership Team that works closely with our UK and France teams to ensure OXB is a global leader in terms of viral vector CDMO capabilities. Your responsibilities in this role would be: Shaping and leading the QC Chemistry, Microbiology & Molecular Biology teams. Operational management of QC, Chemistry, Microbiology, and Biology functions, including HPLC, CE, ELISA, ddPCR, qPCR, cell-based testing, and compendial testing in support of in-process, Drug Substance and Drug Product release, stability, and method qualification activities. Managing the routine environmental, utility, and process monitoring capabilities for the OXB US site. Overseeing the management of raw materials, sample management, equipment calibration and maintenance, and contract lab testing oversight. Drafting test methods, SOPs, protocols, and reports as needed. Reviewing data and ensuring timely product disposition. Authoring a leading QC investigation and CAPAs and performs risk assessments as needed. Trains and coaching of staff and the scheduling of day-to-day lab operations. Supporting the regulatory filings and client project teams as needed. Partnering with cross-functional teams to ensure successful delivery of key milestones. We are looking for: A bachelor’s degree in chemistry, biology, microbiology or equivalent. Minimum 10 years of experience in the pharmaceutical/biotech industry. Proven experience working in a Biotechnology laboratory environment within QC. Experience within a CDMO is preferred. Comprehensive knowledge of Quality Control laboratory quality systems and FDA/EU GMP regulations. Strong technical writing skills. A strategic thinker and proven people manager with the ability to shape teams. Demonstratable strong interpersonal skills with the ability to interact effectively with all levels within the organization, with clients, external third parties, and regulatory authorities. Able to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view. Self-driven, independently motivated, detail-oriented, organized, and excellent problem-solving skills. Effective decision maker that has demonstrated ability to assess, manage and navigate quality and compliance risks. Ability to travel internationally 10% About Us: OXB is a quality and innovation-led viral vector CDMO (Contract Development and Manufacturing Organization) with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies. OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus, and adenoviral vectors. Oxford Biomedica’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise. What’s in it for you: Competitive reward packages Development opportunities Welcoming, friendly, supportive colleagues A diverse and inclusive working environment State of the art laboratory and manufacturing facilities At Oxford Biomedica (US) LLC we are committed to providing equal opportunity to all employees and applicants. Our policy is to recruit, hire, train, and reward employees for their individual abilities, achievements, and experience without regard to race, color, religion, sexual orientation, age, national origin, disability, marital or military status. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States. Collaborate. Contribute. Change lives