Zealand Pharma A/S (Zealand) aims to become a fully integrated biotechnology company leading in delivery of specialty medicines. 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 is now seeking a Clinical QA Manager with compliance insight to support and oversee the GCP and GVP area at Zealand reporting directly to our QA VP.
Pharmacovigilance is currently being established and developed. Therefore, you will have every opportunity of challenge and learning while sharing your own knowledge. You will be the sparring partner and beacon of GCP compliance in Zealand. There are wide ranging opportunities in this position when you meet it with enthusiasm and curiosity.
You will be a part of a QA team that covers all aspects of QA from Documentation, GxP IT, Device, GMP and GCP. You will be welcomed as part of our ambitious and passionate Zealand family working seamlessly and effectively in a fast-paced environment providing life changing medicines.
The successful candidate will be responsible for:
- Ensuring Zealand compliance within GCP and GVP as well as quality oversight of respective CRO’s
- Maintaining a high degree of knowledge of global industry expectations, GCP regulations and providing GCP expert support/guidance to staff in support of GCP operations
- Interpreting GCP regulations and other external requirements and communicating to colleagues in the organization to create solutions and reach a compliant level of operation
- Supporting and actively driving maintenance and further development of the Quality System within the GCP area.
- Participating in the planning and conduct of the clinical QA training program, materials and training classes in collaboration with internal departments.
- Participating in planning activities for Health Authority inspections
- Planning, performing and following up on internal and external audits within GCP including CRO and clinical sites.
- Acting as QA GCP advisor and reviewer of relevant clinical documents including but not limited to risk assessments and clinical protocols.
Some travel is expected
The successful candidate will have:
- A master’s degree in pharmacy, natural science/Biology or similar
- A minimum of 5 years’ experience with Quality Assurance within clinical research and preferably within Pharmacovigilance
- Result oriented mindset and track record in reaching compliant solutions with a team based attitude.
- Lead auditor skills within GCP and Pharmacovigilance
- Hands-on inspection experience
- In depth knowledge of requirements for IT systems used in the clinical area
- Team player attitude with structural approach to compliance in an approachable manner
- Excellent communication skills in English
What Zealand offer
Zealand’s employees are one of the company’s most important assets. We strive to attract, develop and retain the best talents, and to be a company where every employee can thrive.
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 salary package including pension scheme and health insurance, as well as the option of joining the company lunch program, and use of massage, fitness and social facilities.
To find out more about working at Zealand, visit our careers site and view our company video at:
Please send your CV and application at the link below.
For further information, please contact Beirholm Search, Hanne Beirholm
at +45 29440080 or kontakt@ beirholmsearch.dk