QA Senior Specialist/Manager
Ascendis Pharma, Denmark

Ascendis Pharma A/S, a visionary and ambitious pharmaceutical company, offers you an opportunity to become a part of the fast-expanding QA Development Chemistry team. We offer an exciting position with the potential for you to grow your skills within Process Development of existing- and upcoming products in various disease areas from early to late-stage clinical trials.

As QA Senior Specialist, you will be a part of the Chemistry Team in the QA Development department and become responsible for providing QA Support to the CMC development activities related to our various TransCon programs. You will be involved in the different aspects of QA-related activities for development, manufacturing and testing of starting materials, intermediates, and drug substance.

Your job will include building and maintaining QA oversight of outsourced activities, guiding, and setting the stage for the different CMOs to ensure phase-appropriate level for GMP materials intended for use in clinical programs all over the world. Together with a strong team of your CMC colleagues it is your task to set a strong control strategy throughout the supply chain that supports ambitious timelines and still never compromise on patient safety.

This position is a unique opportunity, as you will join a group that oversee all Ascendis Pharma’s development projects, which means that you will follow and participate in the development of both new- and existing Investigational Medicinal Drug Products, both prior to-, during- and after clinical trials.

Furthermore, QA Development Chemistry is team with an international touch, with team members form more than 5 different countries across the globe. This, combined with CMOs located worldwide and team offices in both Copenhagen, DK and Redwood City, US, makes it a truly international workplace. is

Your key responsibilities:

• Represent QA Development Chemistry in the project teams, supporting CMC colleagues within Ascendis Pharma regarding process subjects
• Review and approval of Master Batch Records and Executed Batch Records
• Review and approval of Process Specifications, Analytical Specifications and Stability Study Protocols/-Reports.
• Review and approval of other process- and release documentation from CMOs, including but not limited to Deviations, Changes, Events, CAPAs, Certificates, Statements etc.
• Communication with key personnel at CMOs, including both face-to-face and online meetings
• Ensure the internal quality management system within process 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 establishment of appropriate plans to address the risks.
• Schedule, plan and perform CMO audits.
• Audit internal processes, submission documents etc. in accordance with the audit plan or as requested.
• Establish quality agreements with CMOs
• Keep up to date with changes in relevant guidelines and regulatory requirements and ensure cGMP at Ascendis and CMOs

The preferred candidate:

If you have some of the following experiences, knowledge, and personal qualities, you might be our ideal- and preferred candidate:

• Several years of relevant experience and a relevant academic degree preferably a Master of Science in Pharmacy, Biologics, Engineering, or similar
• Experience with development QA
• Experience with process development and general manufacturing processes for Drug Products
• Knowledge about Drug Product Guidelines and Regulations
• Experience with CMO collaboration
• Pragmatic and yet with attention to the necessary details
• Clear and persistent in your communication, expectations, and requirements to quality
• Cooperative and Capable of ensuring cooperation with many stakeholders
• Working Independently when required, but reaching out when needed
• Proactive, ensuring that projects receive QA-support on a running basis, and reactive when required

The position as QA Senior Specialist requires experience with and knowledge of US and EU GMP regulations and requirements. Furthermore, you should be proficient in English at a professional level, both written and spoken.

Finally, you are an individual that appreciate challenges, you can work in a collaborative environment and possess a can do mentality.

At Ascendis Pharma, you will be part of a QA Development Department of 21 highly experienced colleagues, and you will report directly to the Director for QA Development Chemistry. The Team itself currently consist of 10 colleagues. Additionally, colleagues from your project t

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