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QA Manager

Exciting QA position in a fast-growing biotech company.

 

Ascendis Pharma is currently expanding its QA Development resources within process development to support the development activities of its TransCon development programs.

Ascendis Pharma is therefore looking for a dedicated and passionate QA Manager with process development QA and chemical/engineering experience. As QA Manager, you will be responsible for the QA oversight of outsourced activities at CMOs within the development projects from pre-clinical phase I through phase III. You will be a part of the CMC Core Team, and you will report directly to the Associate Director for QA Development Chemistry.

Main areas of responsibility:

  • CMO responsibility regarding Quality. The CMOs are involved in the development, manufacturing and validation of Starting Materials, Intermediates and Drug Substance
  • Ensure continuous good relations and alignment with CMOs worldwide and stay updated with insights into their methods and processes
  • Responsible for project coordination with internal and external stakeholders
  • Develop and implement GMP improvement projects for systems and procedures including SOPs, policies, forms, and tools
  • Identify and communicate quality or compliance risks and participate in establishment of appropriate plans to address the risks
  • Schedule, plan and perform CMO and/or laboratory audits
  • Review and approval of process relevant documentation
  • Review and approval of manufacturing relevant documentation
  • Handle internal and external change requests and deviations
  • Ensure that the internal quality management system is developed and maintained

Criteria of success in the role will be to understand and support the processes related to manufacturing at the CMOs including review and approve documentation related to this. Moreover, you must actively contribute to the project teams regarding QA support within process development and manufacturing. Furthermore, you should also establish close and high-standard collaborations with the CMOs that Ascendis Pharma works closely with and be a value-adding resource to them in order to assure a high-quality level.

You hold a relevant academic degree – a Master of Science or higher in Chemistry, Engineering, Pharmacy or the like. You have several years of documented experience within QA development. Furthermore, your thorough knowledge and experience within the relevant GMP guidance/legislation will enable you to guide and advice project teams internally at Ascendis Pharma and at CMOs to the appropriate operational GMP level. Experience with PPQ activities and CMOs will be an advantage in this position.

You are proficient in English at a professional level, both written and spoken. Additional language skills are preferred but not required.

You are a highly motivated individual who enjoys being challenged and working in collaborative environments. Strong interpersonal skills are necessary as you will serve as a major contributor and trusted member of the CMC Core Team. A proven ability to communicate with other development staff in a fast-paced environment is crucial. You are confident and able to take fast, well-considered decisions. Finally, attention to details is a prerequisite, as well as a high energy level, focus, and a passion and sense of urgency for developing important new medicines for unmet medical needs.

Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues to advance the exciting and expanding product pipeline.

Travelling: Approx. 20 days per year. Travel is conducted in a responsible way and according to the recommendations from the Danish Health Authorities.

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbor, the canals, and the sea.

For more details about the job or the company, please contact Senior Research Consultant Elisabeth Haun, Unique Human Capital on M: + 45 28 90 33 88. All applications must be submitted in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
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