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QA Manager with analytical development background

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

Ascendis Pharma is currently expanding its QA Development resources within QC and analytical development to support the development activities of its TransCon development programs. Ascendis Pharma is therefore looking to hire a passionate QA Manager with analytical QA development experience to provide effective analytical support to our Contract Manufacturing Organizations (CMOs) across development projects.

You will become responsible for the QA oversight of outsourced activities within analytical development, final method validation, and stability testing activities for Starting Materials, Intermediates, Drug Substance, and Drug Product. Additionally, you will work to ensure continuous good relations and alignment with CMOs worldwide and stay updated with insights into their methods and processes. You will join a QA Development team of 6 highly experienced 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 analytical and stability documentation from CMOs to support establishing reliable and robust analytical methods. Moreover, you must contribute actively to the project teams regarding QA support within analytical method validation and stability.  You will 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.

Main areas of responsibility:

  • Review and approval of validation and stability protocols/reports
  • Perform QC batch record review
  • Handle change requests and deviations
  • Act as support to the CMC teams within Ascendis Pharma regarding analytical subjects
  • Ensure the internal quality management system within analytical development is developed and maintained
  • Develop and implement GxP improvement projects for systems and procedures including SOPs, policies, forms, and tools
  • Identify and communicate quality or compliance risks and participate in establishent of appropriate plans to address the risks
  • Schedule, plan and perform CMO, CRO and/or laboratory audits
  • Audit internal processes, submission documents etc. in accordance with the audit plan or as requested
  • Establish quality agreements with CMOs

You hold a relevant academic degree – preferably a Master of Science in Chemistry, Engineering, Pharmacy or the like. You have as a minimum 4-5 years’ documented experience within analytical QA development and/or practical analytical experience from the pharmaceutical industry within chromatographic analyses (HPLC/UPLC, LC-MS, SE-HPLC), bioassays, compendial methods and microbiological testing. Furthermore, your thorough knowledge and experience within the relevant GMP guidance/legislation will enable you to guide and advice project teams at CMOs to the appropriate operational GMP level. Preferably, you have analytical experience with analysis of proteins and/or peptides. In addition, it will be an advantage if you have experience with GLP.

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 Jeanne Dederding, Unique Human Capital M +45 28 74 58 71. 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
Søren Frichs Vej 42R
8230 Aabyhøj
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