QA Specialist, QA for QC, Commercial Operations

Are you passionate about quality and would you like to be a part of our high performing QA team in a fast growing and innovative international company? Are you motivated to play an important role in ensuring the quality and compliance of our products and processes?

The role
As our new QA for QC specialist, you will support and maintain the quality oversight for QC related activities with internal stakeholders and for our contract organizations for commercial manufacturing and release of drug substance and drug product.

You will join a department with highly qualified and motivated colleagues organized in four teams and report directly to Director in QA for QC within Commercial QA.

Ascendis Pharmais a fast-growing, dynamic biopharmaceutical company with Headquarters in Denmark that offers you room to grow and the freedom to take responsibility and make a difference for patients every day.As a member of our global team, you will work with highly skilled and passionate colleagues to advance our exciting product pipeline.

You will be responsible for:

• Review and approval of analytical documentation from CMOs and/or testing laboratories, including but not limited to analytical method validations, laboratory records, deviations, laboratory investigations, OOS, change controls, CAPAs, and stability protocols, reports etc.
• Support Tech transfer from development to commercial and the associated analytical activities
• Follow-up on trends with Ascendis Subject Matter Experts and CMOs to ensure methods and processes are improved.
• Support commercial Ascendis Pharma Quality Management Review process, the annual product quality reviews, and other projects.
• Review and give input to Quality Agreements.
• Participate as needed in inspections and internal and external auditing.
• Communication with CMOs including face-to-face meetings and teleconferences.
• Develop and implement GxP improvement projects for systems and procedures including SOP´s, policies, forms, and tools.
• Keep up to date with changes in relevant guidelines and regulatory requirements and ensure cGMP at Ascendis Pharma and CMOs.

Your professional qualifications
You have an educational background as Master of Science in Pharmacy, Chemistry, Biotechnology, Engineering or similar and bring 5-10 years of experience preferably from working within Quality Assurance in the life science industry. In addition, you also have experience from working in or being QA for Analytical Development and/or Quality control.

It is a great advantage if you have experience from commercial operations, including participation in various projects as a QA representative. You are used to working with quality processes including deviations, change controls and CAPAs. At Ascendis Commercial QA we work primarily with electronic records and documentation in our electronic QMS Veeva, so an intuitive understanding of electronic systems is also a great advantage as well as solid experience of standard Microsoft tools like MS office, MS Teams, Sharepoint etc. Proficient in English at a professional level, both written and spoken.

You have experience within the regulatory field and regulations as well as experience with guidelines for analytical methods. Furthermore, you are competent within stakeholder management and possess a good business understanding.

You aremeticulous with a high level of attention to details. You are clear and persistent in your expectations and requirements to quality, while at the same time being pragmatic and flexible in your approach. You are self-motivated and able to work independently and finally you can communicate clearly, both internally and externally towards CMOs and other stakeholders.

As a person you bring energy and a positive mindset, and you enjoy being part of a team with many and varied tasks and functions. You will join a skilled and helpful team in an exciting environment with great flexibility.

Travel: 5-20 days per year.

Office location: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a nice view of the harbor, the canals, and the sea.

For more details about the company, please visit out website www.ascendispharma.com All applications must be submitted in English and are treated confidentially.

Applications will be evaluated when received, so please apply as soon as possible.

Hellerup