QA Specialist, Commercial Drug Product & Finished Goods

Job title:

QA Specialist, Commercial Drug Product & Finished Goods

Company:

Ascendis Pharma

Job description

Are you passionate about quality oversight and continuous improvement in the pharmaceutical industry? Do you have experience in overseeing CMOs, reviewing quality documentation, and ensuring cGMP compliance?If so, now is your chance to join Ascendis Pharma as our new QA SpecialistAscendis Pharma is a fast-growing global biopharmaceutical company committed to making a meaningful difference in patient’s lives. We have locations in Denmark, Germany, the United States, the UK, Italy, Spain, and France.Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs.Today, we are advancing programs in Endocrinology Rare Disease and Oncology. In addition, we collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets.Ascendis Pharma A/S offers you an opportunity to become a participant in the further establishment and effective running of QA Commercial Operations. You are offered a position with potential to grow your professional and personal skills and to be part of the introduction of new products to be marketed.As QA specialist, you will be a part of the well-functioning QA Drug Product and Finished Goods team in the QA Commercial Operations department, with responsibility for quality oversight of sterile production of drug product and packaging operations for commercial products performed at our Contract Manufacturing Organizations (CMOs). We have a close collaboration with our CMOs and process- and packaging SMEs internally at Ascendis Pharma.Your key responsibilities:We work with all aspects of quality oversight, i.e., your responsibilities will cover a broad range of tasks, documents, and assignments.

• You will work with oversight of one or more CMOs in our supply chains with respect to review and approval of documentation from these CMOs, including batch documentation, deviations, changes, CAPAs, CPVs, stability studies, QMRs, quality agreements etc.
• Communication with key personnel at CMOs, including face-to-face meetings, teleconferences, and audits
• Participate in CMO evaluations and product quality reviews
• Keep up to date with changes in relevant product guidelines and regulatory requirements and ensure cGMP at Ascendis and CMOs
• Drive and take responsibility in agreed tasks and matters
• Continuously optimize our work processes and the way we execute quality oversight

Qualifications and Skills:
You hold a relevant academic degree – preferably a master’s degree in natural science – and 5-10 years of experience within QA or manufacturing.
Furthermore, you have:

• Solid understanding and hands-on experience with GMP
• Qualification to become a Qualified Person (QP)
• Proven ability to clearly communicate expectations and quality requirements

Key competencies:
You are a strong team player, analytical, and have a can-do attitude.
You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.To succeed in this role, we also expect you to be:

• Critical thinker with a pragmatic approach and attention to detail
• Clear and assertive in communication with stakeholders
• Able to foster smooth collaboration with multiple stakeholders

Preferred experience:

• Experience with sterile production and packaging operations
• Experience working with Contract Manufacturing Organizations (CMOs)

The position as QA 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, and you master MS Office.At Ascendis Pharma, you will be part of a stimulating, informal, and innovative working environment, where you will interact with very skilled colleagues and partners to deliver on Ascendis’ ambitious corporate goals. You will be part of an expanding QA-organization overseeing development, clinical, and commercial activities.Travelling: 5-20 days/year.Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals, and the sea.For more details about the job or the company, please contact QA Director, Nina Bornhøft Nielsen, M +45 30191902. All applications must be submitted in English and are treated confidentially.

Expected salary

Location

Hellerup, Hovedstaden

Job date

Fri, 07 Mar 2025 23:33:35 GMT

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