Jobbeschreibung
We are a strong community: with more than 2,000 employees worldwide, we are committed to improving human health. Our work is more than just a job. With a career at medac, you can make a real difference in the industry. Look into this job opportunity and become part of an exceptional workforce.
At our location in Wedel near Hamburg, we are looking for a Quality Assurance Manager GCP (m/f/d).
- Support the responsible management in strategic planning and decision making
- Identify compliance gaps, potential or actual, as well as options for compliant outcomes and risk mitigation, and drive implementation across functional areas
- Consult and give direction on quality assurance and GCP compliance questions from all functional areas involved in clinical trials
- Conduct investigational site, vendor, system, and process audits
- Prepare and support clinical trial teams and investigational sites before, during, and after regulatory inspections
- Assist and represent Quality Assurance during regulatory inspections from e.g., local authorities, EMA, FDA, or PMDA
- Bachelor's degree, preferably in physical science, life science, pharmacy, or equivalent experience required
- Several years of experience in the pharmaceutical industry in GCP quality assurance (strongly preferred), clinical operations, or clinical compliance function
- Thorough understanding / knowledge of GCP requirements
- Able to work independently and manage priorities, as well as operate as a team member
- Solution-oriented and able to present information in an objective manner that supports compliance and operational success
- Collaboration and partnering at all levels of the organisation to accomplish deliverables and meet quality standards
- Excellent written and verbal communication skills in English and German
- Willingness to travel 10–15%
- Flexible and autonomous – In many areas of the company, our employees can organise their working hours as they wish – and work up to 60% remotely.
- Relaxation – 30 vacation days a year and vacation pay.
- Special performance deserves special appreciation – At medac, all employees share the company's success through performance-based bonus payments.
- Optimum provision – With a company pension scheme and capital-forming benefits.
- Attractive additional benefits – From corporate benefits and accident insurance to external employee counselling.
- We promote individual development – The medac academy offers a wide range of further and advanced training courses, including language courses and e-learning.
- Healthy food from regional cuisine – Our company restaurants in Wedel and Tornesch offer a varied selection of delicious dishes every day.
- Take the train to work – No problem; we subsidise the Deutschland-Ticket and offer BusinessBike leasing for maximum flexibility.
- Fit and healthy – We offer a wide range of sports activities and health services: from company sports and relaxation courses to mobile massages.