Quality Operations Director

Quality Operations Director

Catalent

Brussels, Belgium

Position Summary

The Quality Operations Director 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 Operations at the site is the most responsible person for batch disposition and may serve as the Qualified Person (QP) for the site. The Director of Quality Operations 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.
  • Being part of the Site Leadership Team representing the QRA function for the site and supporting site mission/strategy
  • Prepare, approve, and manage Quality departmental budget. Authority to approve or reject, starting materials, packaging materials, and intermediate, finished products, and to evaluate batch production records as the QP (or provides direction as the manager of the site QP).

The Candidate

  • Bachelor’s degree in biology, chemistry or closely related field (e.g. natural sciences, engineering) is strongly preferred
  • 8 -10 years’ directly related experience in pharmaceutical fields including managerial roles
  • Experience with sterile drug product manufacturing is strongly preferred, extensive knowledge of Quality Assurance and Quality Control
  • Experience leading a manufacturing site operation (e.g. Quality Operations, QC Operations, Manufacturing) is strongly preferred
  • QP certification is strongly preferred
  • Proven ability to lead a large, multi-level/multi-shift organization (e.g. 50+ employees) effectively

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Belgium     Manager and Executive     Manufacturing and Logistics     Quality Assurance     Catalent    

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies