QA Manager, QA Commercial Operations, Ascendis Pharma / 1783
Ascendis Pharma A/S is an international company with offices in Copenhagen, Germany, and the US. Ascendis Pharma is building an integrated biopharmaceutical company to advance its pipeline of long–acting prodrug therapies. They employ their proprietary “TransCon” technology platform to generate therapeutics with best-in-class profiles that address large markets with significant unmet medical needs. Ascendis Pharma has a diversified and balanced high-value product pipeline, including internal programs and partnerships with market leaders.
Place of work: 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. Read more at www.ascendispharma.com.
QA Manager, QA Commercial Operations
Visionary, Ambitious and Fast-growing Biotech company
- Introduction of new products to be marketed
- Cooperation cross functional and with many stakeholders
- Potential to grow your professional and personal skills
- Key role in analytical testing on different manufacturing stages
QA Drug Substance team, a part of the QA Commercial Operations department, is responsible for oversight of starting materials, intermediates, and Drug Substance for commercial products. As the department is growing, they are now looking for a QA Manager. You will be part of a dynamic team in a stimulating international environment, where it is expected that you like and are used to work in a role with great influence. In the position you will act as SME, and you are a leading person in QA Commercial Operations for the quality oversight of analytical testing performed on the different manufacturing stages.
You will act in close collaboration with several external Contract Manufacturing Organizations (CMOs) and process SMEs internally at Ascendis Pharma. It is expected that you find solutions and that you can think out of the box within your area of responsibility. You go through different processes to drive the area most effectively for the team and the company. The team is characterized by strong cooperation, high quality, result orientation and speedy realizations of the goals in an entrepreneurial and sometimes hectic environment.
You are given the opportunity to put your mark on the job in a rapid growing company, where you get the chance to make great results. You will be referring to the Director, QA Commercial Drug Substance.
Your key responsibilities include:
- Review and approval of documentation from CMOs, including batch records, deviations, changes, CAPAs, stability studies, etc.
- Communication with key personnel at CMOs, including international face-to-face meetings and teleconferences
- Participate in CMO audits, evaluations, and product quality reviews
- Keep up to date with changes in relevant product guidelines and regulatory requirements and ensure cGMP at Ascendis Pharma and CMOs
- Drive and take responsibility in agreed tasks and matters
- Continuously optimize work processes and the way of executing quality oversight
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 Pharma’s ambitious corporate goals. You will be part of an expanding QA-organization overseeing development, clinical, and commercial activities. You are offered a professional on-boarding program and relevant training.
The role requires experience as QA and preferably you have some experience working with or within a CMO. As we are looking for more candidates, you may have experience within some of the following areas:
- Master’s degree as Chemist, Chemical Engineer, or the like
- Minimum 5-10 years of experience within the QA area – maybe as a Senior Specialist
- Experience with biologics, chemical production or similar
- Experience with drug substance and or drug product
- Know how within upstream/downstream processes
- You are a trained and experienced Auditor
- QA for QC
- Knowledge of US and EU GMP regulations and requirements
- Working with CMOs
Excellent knowledge of MS Office and fluency in English with good verbal and written communication skills is a given as well as acceptance of travelling (5-20 days per year - where flexibility/variation is possible).
As a person you are ambitious and pro-active and see the benefits in going the extra mile. At the same time, you are pragmatic and yet with attention to the necessary details that is required in a position like this. You communicate in a clear and persistent way with focus on expectations and requirements to quality. The group is based on a strong team spirit, cooperation and willing to help and go the extra mile for each other when needed. Therefore, you must be a strong team player, who in a natural way always strive for smooth collaboration with your colleagues and external stakeholders.
Best Talent is responsible for the recruitment process and will be handling your application on a confidential basis. Forward your application marked ”1783/QA Manager” to email@example.com. Read more about Ascendis Pharma on www.ascendispharma.com. We will interview candidates for this position ongoing, but please apply as soon as possible. You can read more about Best Talent at www.besttalent.dk.