Zealand Pharma A/S (Zealand) is a Copenhagen-based biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. We are passionate about improving the quality of life for patients with metabolic and gastrointestinal diseases, and other specialty or rare disease areas with significant unmet medical needs. Zealand was founded in 1998 in Copenhagen, Denmark, and has presence the U.S. as well.

Zealand is now seeking a Clinial QA Manager with compliance insight to support and oversee our GCP activities and clinical operations at Zealand, with direct report to our QA GCP Director. You will be a part of a QA department that covers all aspects of QA covering Quality Systems, GxP IT, GMP & Device and GCP. In the Clinical QA team you will be a part of a dedicated group with a positive a structured mindset and we thrive on the close dialogue we have with our colleagues and partners while we aim to secure compliance acting as one team. You will be welcomed as a part of our ambitios and passionate Zealand family working seamlessly and effectively in a fast-paced environment providing life changing medicines.

Job Profile
The successful candidate will be responsible for:

• Ensure Zealand compliance with GCP and oversight of respective QMS/SOPs.
• Provide GCP expert support/guidance to staff in support of GCP operations based on a high degree of knowledge of global industry expectations, GCP regulations and (20%).
• Interpret GCP regulations and other external requirements and communicate to colleagues in organization to create solutions and reach a compliant level of operation.
• Support and actively drive maintenance and further development of the Quality System within GCP area.
• Participate in compliance training within Clinical QA, contribute to materials and training classes in collaboration with internal departments.
• Participate in preparation activities of Health Authority inspections.
• Plan, perform and follow up on internal and external audits within GCP including but not limited to CRO and clinical sites.
• Be the sparring partner and lighthouse of GCP compliance in Zealand.

Travel is expected to take up to 15 % of your time.

Candidate Profile
The successful candidate will have:

• A master degree in life science, pharmacy, or similar.
• A minimum of 5 years experience with Quality Assurance within clinical research and drug development.
• Result oriented mindset and have a track record in reaching compliant solutions with a team based attitude.
• Lead auditor skills within GCP.
• Computer Validation skills in the GCP area.
• A teamplayer with structural approach to compliance in an approachable manner.
• Excellent communication skills in English both verbally and in writing.

What we offer
Our employees are fundamental to our success, and we continue to be able to attract and retain people with vast experience and talent. We have a unique culture, characterized by excellent teamwork and strong engagement across the organization.

Our work environment is characterized by strong cross functional team-work, room for individual performance and development, informality and respect, high work-ethics and engagement, and fun.

At Zealand, we understand the value of a diverse workforce. As an employee, you will be part of an innovative, cross-disciplinary and cross-cultural working environment.

We offer a combined compensation package which includes a base salary, pension, and bonus. We care about our employees’ well-being and offer health insurance, use of massage, fitness, and a range of social clubs and activities. To find out more about working at Zealand, visit www.zealandpharma.com.

Application
Please apply no later than August 30, 2022.
For further information, please contact Director GCP QA Helle Maach Møller, at hmm@zealandpharma.com.


About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Additionally, the portfolio includes clinical license collaboration with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals. Zealand is based in Copenhagen (Søborg), Denmark. For further information about the Company's business and activities, please visit www.zealandpharma.com or follow Zealand on LinkedIn or Twitter @ZealandPharma.