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Senior Director of Quality Systems and Compliance

Join a Fast Growing Biotech Company

As Senior Director of Quality Systems and Compliance at Ascendis Pharma, the main success criteria is to develop a high performing team, owning the company´s Quality System and driving it´s successful execution, as well as driving the company’s compliance programs including licensing and inspection preparedness.

You will be part of the Ascendis Pharma Quality Leadership Team and become part of a very exciting journey establishing a superior biotech Quality Organization for product development and CMO manufactured products.

Your main responsibilites are:

  • Ownership of the company Quality Manual, Quality Metrics, and respective reporting to senior management
  • Ownership of key systems like the Quality Documentation System, Training System, CMO qualification system, audit, and complaint handling
  • Licensure and Inspection Preparedness, Authority Network
  • Compliance/Enterprise Risk Management

Ideally, you want to work with QS processes, support submissions, and lead regulatory authority inspections. You hold a relevant degree within e.g. Pharmacy, Biology, Biochemistry, Chemistry or the like. However, most important is your experience with QMS, global regulations, and your ablity to implement and drive processes involving many global stakeholders.

The successful applicant will have a proven leadership record and a track record working with Quality Management Systems driving global compliance in an international pharma, biotech or medical device environment.

The following qualifications are desirable:

  • A minimum of 10 – 15 years experience within Quality and an understanding of the manufacturing processes as well as excessive knowledge and application of global regulations and guidelines in relation to the medicinal products industry
  • Extensive experience in licensure of products, facilities, and global compliance including prior approval or prior licensure inspections and cGMP inspections
  • Experience with large stakeholder management and metrics reporting to senior management teams

You are proficient in English at a professional level, both written and spoken. You have excellent presentation skills and are familiar with presenting to authorities and to stakeholders at all levels and functions of the company.

You are a leader and a pragmatic person with an open and communicative approach, and you have the ability to develop teams as well as effective working relationships with employees at all levels, and you enjoy being in a position with an international reach. You are flexible, persistent, and resourceful.

Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues on advancing an exciting product pipeline.

Travelling: Approx. 20-30 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 Senior Consultant Jannie Jensen, Unique Human Capital on M +45 29 72 78 86. All applications must be in English and are treated confidentially.

 

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.


For further information, please see www.ascendispharma.com

Kontakt
Unique Human Capital A/S
cvr: 31502705

Stamholmen 157, 1. tv
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
T +45 7020 6700
Marselis Tværvej 4
8000 Aarhus C
Unique Human Capital Poland Sp. z o.o.
ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
Poland
T + 48 22 291 32 20