Director, Quality – Biologics, Oxford

Location: Harwell, UK

Position Summary

The Director of Quality is responsible for setting the strategic direction, properly staffing and maintaining the Quality Management Systems (QMS) to assure the site is compliant with regulatory, Corporate, and customer requirements. They are responsible for establishing and maintaining the site metrics, management review, and building a Patient First culture at the site. The Director of Quality at the site is the most responsible person for batch disposition. The Director of Quality is responsible to provide project guidance and support and work with customers to resolve quality concerns as appropriate.

The Role

Serve as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit. Develop and implement Site Quality Plan, Quality Unit objectives and related procedures.

Maintain an effective Quality Management System (QMS) that aligns with regulatory requirements/expectations.

Interface with all other departments to ensure compliance with cGMP.

Monitor site compliance to FDA, EU and all other applicable requirements.

Ensure site procedures align with Corporate policies.

Direct a team of Quality professionals. Provide development and disciplinary actions (as needed) to assure the department remains engaged and motivated.

Analyze, resolve, or assist in solving compliance and customer issues.

Ensure regulatory and customer audits are managed successfully and any responses submitted in a timely manner.

The Candidate requirements:

Bachelor’s degree in chemistry or closely related field (e.g. natural sciences, engineering) is strongly preferred

10+ years of Biologics Drug Substance experience in pharmaceutical fields including managerial roles

Experience leading a manufacturing site operation (e.g. Quality Operations, QC Operations, Manufacturing) is strongly preferred

Ability to work effectively under pressure to meet deadlines.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.