Director Quality, Head Pharmacist

Job Title: Director Quality, Head Pharmacist

Location: Beinheim, France

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The Director Quality, Head Pharmacist is responsible for setting the strategic direction, properly staffing and maintaining the Quality Management Systems (QMS) to assure the site is always compliant. 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.

As Head Pharmacist, you will be responsible to ensure legal pharmaceutical responsibility for the site.

The Role

• Direct a team of Quality professionals. Provide development and disciplinary actions as needed to assure the department remains engaged and motivated.
• Manage and drive relations with French and international authorities & ensure compliance with the CSP (French Health Code), GMP (Good Manufacturing Practices).
• Responsible for the management of manufacturing licenses, GMP certificates, SMF (Site Masterfile) and import and export licenses.
• Organize and monitor all the company's pharmaceutical operations, including research and development, manufacturing, control, release, pharmacovigilance, batch tracking and withdrawal, distribution, import and export of medicines and corresponding storage operations.
• As a Qualified Person/QP, ensure responsibility for the compliance of productions upon departure from the site or even the release of lots according to agreements with customers.
• Investigate root causes of deviations, non-conformances, and complaints, and implement appropriate corrective and preventive actions (CAPAs).
• Report to other company or organization leaders any obstacles or limitations to the exercise of these responsibilities.
• Informing the General Manager of the competent authority in case of disagreement on the application of the rules adopted in the interest of public health.
• Participate in the deliberations of the governing, administrative, management or supervisory bodies, or those of any other body with an executive office, when these deliberations relate to the performance of the tasks under its responsibility or may affect them.
• Host and manage local Quality Management Review meetings to drive compliance and continuous improvement initiatives.
• Support and execute all processes aligned with business objectives inclusive of budget and headcount management.
• Other duties as assigned.

The Candidate

• License to practice as a Head Pharmacist/Qualified Person/Pharmacien Responsable with at least 3-4 years in a similar leadership position working for a pharmaceutical company’s quality function.
• Experience in Softgel manufacturing is highly desirable, including knowledge of gelatin encapsulation processes and softgel-specific regulatory requirements.
• Ability to bring projects to a timely completion using Catalent systems.
• Good working knowledge of the subject area.
• Knowledge of cGMP, GLP, ICH, and EP, USP, BP regulations or guidelines.
• Expert knowledge as head pharmacist and qualified person according to French Health Code art. R.5124-36.
• Experience of working with softgel development and manufacturing operations.
• Languages: French (main preference native speaker) & English, business fluent.
• Demonstrable leadership experience at Catalent may be considered in place of external experience.

Catalent offers enriching opportunities to advance your career! Join the global leader in drug development and manufacturing and help us deliver over 7,000 products that save and improve the lives of patients worldwide. Catalent is an exciting and growing international company where employees work directly with pharmaceutical, biopharmaceutical, and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to market. Catalent produces over 70 billion doses annually, and each will be used by someone who relies on us. Join us to make a difference.

Personal initiative. Dynamic pace. Meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an equal opportunity employer and does not discriminate on the basis of any protected characteristic under local law.