Senior Packaging Operations Manager

Vor 3 Tagen

Zug, Zug, Schweiz Galderma Vollzeit
About the Role

We are seeking an experienced Senior Packaging Operations Manager to join our team at Galderma. As a key member of our operations team, you will be responsible for ensuring seamless coordination between commercial drug product Contract Manufacturing Organizations (CMOs) and other third-party suppliers.

The successful candidate will have a strong technical understanding of the biopharmaceutical packaging process and extensive knowledge of current Good Manufacturing Practices (cGMPs). They will also have demonstrated experience with preparing/reviewing annual product review/product quality review reports.

Key Responsibilities
  1. Serve as Subject Matter Expert (SME) for primary and secondary packaging (for small molecules)
  2. Develop and maintain good working relationships with contract manufacturers
  3. Coordinate periodic CMO Manufacturing meetings, preparing minutes and tracking completion of action items
  4. Maintain and follow through a consolidated Manufacturing action log to ensure all manufacturing-related actions are completed on time
  5. Prepare Annual Product Reports with Manufacturing CMOs according to the company's needs
  6. Work with CMOs and company participants to schedule and coordinate Steering Committee Meetings
  7. Work with Quality Group and Manufacturing SMEs to ensure Quality Events are managed and communicated appropriately to ensure timely resolution and closure
  8. Ensure CMOs remain current and compliant with all GMP-related requirements, guidelines, and procedures
  9. Provide onsite process coverage as person-in-plant as needed
Requirements
  • Bachelor degree or higher in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience
  • 5-10 years of progressively responsible experience as a packaging engineer for small molecules is an absolute must
  • Strong technical understanding of the biopharmaceutical packaging process
  • Extensive knowledge of current Good Manufacturing Practices (cGMPs)
  • Demonstrated experience with preparing/reviewing annual product review/product quality review reports
  • Able to operate effectively and with a strong sense of urgency in a fast-paced environment
  • Good communicator: clear, concise, well organized, and appropriate to the audience
  • Business fluency in English; additionally, German and/or French is a plus

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