Senior Professional, QA Commercial Drug Product & Finished Goods

Description

Are you passionate about Quality Assurance Do you have experience working in the pharmaceutical industry

If so now is your chance to join Ascendis Pharma as our new Senior Professional QA Commercial Drug Product & Finished Goods.

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients lives. Guided by our core values of Patients Science and Passion we are applying our innovative TransCon technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup Denmark research facilities in Heidelberg Germany and additional offices across Europe and the United States we are advancing programs in our Endocrinology Rare Disease portfolio. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

We are seeking a passionate Senior Professional to join our growing team. As a key member of the Ascendis Pharma team you will play a crucial role in handling the daily operations such as batch review of drug product and finished goods Quality records (Deviations Change controls etc.) and collaboration with our internal and externals stakeholders (CMOs producing drug product and performing secondary packaging). This is an exciting opportunity to work in a fast-paced environment collaborate with cross-functional global teams working together to achieve extraordinary results.

You will be joining the QA Commercial Drug Product & Finished Goods team consisting of 6 colleagues and report directly to Nina Bornhøft Nielsen Senior Director who is based in Hellerup office Tuborg Boulevard 12. You will also be based in Hellerup.

We work with all aspects of quality oversight in relation to CMO production and your responsibilities will cover a broad range of tasks documents and assignments.

Your key responsibilities will be:

• Review of batch documentation
• Review of deviations CAPAs and other relevant documentation
• Collaboration with internal and external stakeholders (CMOs)
• Support in planning and oversight of department tasks e.g. release
• Support departmental tasks including SOP updates and APQR input

Qualifications and Skills:

You hold a masters degree in natural science preferably MSc. Pharm. and 2-5 years of experience within the pharmaceutical industry

Furthermore you have:

• GMP knowledge
• Quality mindset - Critical thinking pragmatic and yet with attention to the necessary details
• Cooperative and striving for smooth cooperation with many stakeholders.
• Experience with CMO collaboration
• Thrives in a multicultural international and highly dynamic setting

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 able to thrive in working with routine tasks with the opportunity to add on more complex assignments be proficient in English at a professional level both written and spoken and you master MS Office.

Travel: Potentially 5-10 days per year.

Office: Tuborg Boulevard 12 2900 Hellerup

Apply now.

We evaluate applications when received so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.

To ensure your application is reviewed please submit it through the specified platform - applications sent by email or other channels will not be evaluated.

For more details about the position or the company please contact Nina Bornhøft Nielsen Senior Director QA Commercial DP&FG

You can learn more about Ascendis by visiting our website

Applications must be submitted in English and will be treated confidentially.

A note to recruiters:

We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.

Required Experience:

Senior IC

Employment Type : Full Time
Experience: years
Vacancy: 1