Amgen Senior Manager Plant Quality Assurance in Breda, Netherlands

Amgen is a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients. We provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and pioneering spirit that marked our early days as a biotechnology innovator. We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities such as this job opportunity.

Amgen Breda receives its products as semi-manufactured goods, which are then packed country-specific, stored and eventually shipped to various countries worldwide.

Dedicated Amgen staff in the Netherlands are working on supply chain processes, Engineering, clinical research and marketing and sales of our medicines. We encourage our employees to have fulfilling and meaningful careers. We offer challenging assignments, career development programs, and valuable growth opportunities.

Currently we are looking for a Senior Manager Plant Quality Assurance.

As the Senior Manager Plant QA within ABR Site Quality, you are responsible to lead and motivate the multiple shift Plant QA and Batch Release team. You play a key role in Amgen's primary mission to serve patients with high quality medicines. While ensuring Quality and Compliance, you also assume responsibility to implement LEAN methodology into the QA processes, to support future growth and changing business needs.

As a Senior Manager Plant Quality Assurance, you:

  • Are responsible for disposition of all non-clinical materials

  • Ensure on time resolution of non-conformances and OOS

  • Establish and maintain effective working relationships with Production, Maintenance and Warehouse/Distribution staff

  • Ensure that Quality policies, procedures and programs are properly implemented in daily GxP operations

  • Participate in internal and external audits and projects as required

  • Provide guidance and direction to Quality, Production, and M&E staff with regards to compliance with Quality policies and procedures

  • Partner with Production staff in performing risk analysis and the establishment of quality limits and requirements

  • Consolidate and report team performance metrics and drive continuous improvement activities

Minimum Requirements

  • Pharmacist Qualification or related education

  • At least 5 years of related Quality Assurance experience in the pharmaceutical or medical device industry with progressively increasing responsibility and demonstrated experience in investigations, change control, validation and/or audits

  • At least 3 years of supervisory experience

  • Deep understanding of Global Regulatory guidelines (Good Manufacturing Practice) with the ability to interpret and apply in both routine and non-routine cases

  • Extensive knowledge of manufacturing processes and operations

  • Extensive knowledge of GxP change control, investigations, validation and training requirements

  • Fluent in English language

Preferred Requirements

  • Pharmacist Qualification or related education

  • At least 10 years of related Quality Assurance experience in the pharmaceutical or medical device industry with progressively increasing responsibility and demonstrated experience in investigations, change control, validation and/or audits

  • At least 5 years of supervisory experience

  • Deep understanding of Global Regulatory guidelines (Good Manufacturing Practice and Good Laboratory Practice) with the ability to interpret and apply in both routine and non-routine cases

  • Extensive knowledge of warehouse and manufacturing processes and operations

  • Extensive knowledge of GxP change control, investigations, validation and training requirements, with proven ability to apply to business improvement

  • Fluent in Dutch and English language

Why join Amgen?

Amgen is a Fortune 150 company and one of the world's leading biotechnology companies operating in nearly 100 countries around the world. We encourage open dialogue and professional debate, and we collaborate with world-class talent and institutions around the globe. We believe in rewarding those who do rewarding work and are committed to providing careers that can help turn the tide of serious, life-interrupting illnesses.

Please note: An online assessment (personality questionnaire) is part of the recruitment process