Job Description

We use science to save lives, and so can you .

We are currently recruiting for an Associate Director of Quality Assurance (QA) Operations to join our Quality organization. Reporting to the Head of Quality (US), this position is responsible for the quality oversight of site operations, including manufacturing, facilities, engineering, warehousing, supply chain, validation, and quality control activities.

The role is onsite, based out of our Bedford, MA facility and is a key member 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:

• Provide strategic quality oversight of GMP manufacturing and testing operations in a dynamic gene therapy manufacturing facility driving product release to support client programs.
• Provide quality expertise on quality management system elements, including but not limited to deviations/investigations, corrective and preventative actions (CAPAs), change controls, risk assessments, and product complaints.
• Ensure significant quality risks are escalated and mitigated in a timely manner.
• Lead continuous improvement projects to enhance the overall health of the quality systems and drive efficiencies in operational processes.
• Lead and manage clients’ expectations on OXB quality deliverables.
• Partner with functional leads to establish quality requirements and drive program maturity as the organization evolves and continues to integrate across the global OXB network.
• Support QAV activities for ongoing implementation of new GMP equipment and computerized systems.
• Support preparation for and participate in regulatory inspections, client audits, and internal audits.

We are looking for:

• Bachelor's degree in chemistry, biology, microbiology or equivalent.
• Minimum 10 years of experience in the pharmaceutical/biotech industry.
• Comprehensive knowledge of GMP regulations and guidelines.
• Experience in several disciplines of Quality which may include Quality Operations, Compliance, Quality Systems, Quality Control, Quality Assurance Validation.
• Excellent people skills: the ability to interact effectively with all levels within the organization, external third parties, and with regulatory authorities.
• Demonstrate the OXB values (responsible, responsive, resilient, and respect) in everyday activities.
• Effective decision makers that have the demonstrated ability to assess and manage quality and compliance risks.

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.

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