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QA Manager with experience in aseptic processing

Join the QA Development Team in a leading and fast-growing biotech company

Ascendis Pharma is currently expanding its QA Development resources within Drug Product development and aseptic manufacturing to support the development activities of its TransCon development programs. Ascendis Pharma is therefore looking to hire a passionate QA Manager with QA development experience from aseptic production to provide effective support to our Contract Manufacturing Organizations (CMO) across development projects.

You will become responsible for the QA oversight of our outsourced aseptic manufacturing of Drug Product at various CMOs. Additionally, you will work to ensure continuous good relations and alignment with CMOs worldwide and stay updated with insights into their processes and systems. You will join a QA Development team of 6 highly experienced QA colleagues, and you will report directly to the Senior Director for QA Development.

Criteria of success in the role will be to review and approve documentation from CMOs to support aseptic manufacturing of Drug Product on time and with a high quality for our clinical studies. Moreover, you must contribute actively to the project teams regarding QA support. Furthermore, you must 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.

Main areas of responsibility:

  • Ensure that documentation, procedures and processes supporting development programs are maintained in compliance with company and industry standards and global regulations
  • Review and approval of validation and stability protocols/reports
  • Review and approval of manufacturing related documentation
  • Perform batch record review including evaluation if the batch is fit-for-purpose
  • Handle change requests and deviations
  • Act as support to the CMC teams within Ascendis Pharma regarding Drug Product development
  • Schedule, plan, and perform CMO audits. Prepare and submit audit reports for review and input
  • Communicate audit results to stakeholders
  • Assist with GMP inspection readiness activities for regulatory authority inspections and coordinate tracking of document requests, responses, and supporting documentation during inspections
  • Develop and implement GxP improvement projects for systems and procedures including SOPs, policies, forms, and tools
  • Audit internal processes, submission documents etc. in accordance with the audit plan or as requested
  • Establish and update quality agreements with CMOs

You hold a relevant academic degree – preferably a Master of Science in Chemistry, Engineering, Pharmacy or the like. You have minimum 4-5 years’ experience of documented experience within QA and/or practical manufacturing experience from the pharmaceutical industry within aseptic processing and environmental monitoring. Furthermore, your thorough knowledge and experience within relevant GMP guidance/legislation will enable you to guide and advise project teams internally and at CMOs to the appropriate operational GMP level. Preferably, you have experience with Process Performance Qualification.

You are proficient in English at a professional level, both written and spoken, and you master MS Office.

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 project development teams. A proven ability to communicate with other development staff in a fast-paced environment is crucial. Finally, attention to detail is a prerequisite, as well as a high energy level, focus, and a passion and sense of urgency for developing important new medicines for devastating diseases.

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 our exciting product pipeline.

Travelling: Approx. 20 days per year.

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 Research Consultant Maiken Hvidkjær Jensen, Unique Human Capital on M +45 22 51 94 66. All applications must be submitted in English and are treated confidentially.

Unique Human Capital A/S
T +45 7020 6700
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cvr: 31502705
Stamholmen 157, 1. tv
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
Marselis Tværvej 4
8000 Aarhus C
Unique Human Capital Poland Sp. z o.o.
+48 531 785 064
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ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
Poland