About medac
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).
Quality Assurance Manager GCP (m/f/d)
Your tasks
- 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
Your profile
- 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%
Our offer
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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.
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Relaxation - 30 vacation days a year and vacation pay.
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Special performance deserves special appreciation - At medac, all employees share the company's success through performance-based bonus payments.
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Optimum provision - With a company pension scheme and capital-forming benefits.
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Attractive additional benefits - From corporate benefits and accident insurance to external employee counselling.
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We promote individual development - The medac academy offers a wide range of further and advanced training courses, including language courses and e-learning.
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Healthy food from regional cuisine - Our company restaurants in Wedel and Tornesch offer a varied selection of delicious dishes every day.
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Take the train to work - No problem; we subsidise the Deutschland-Ticket and offer BusinessBike leasing for maximum flexibility.
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Fit and healthy - We offer a wide range of sports activities and health services: from company sports and relaxation courses to mobile massages.
Are you looking for a new professional challenge and a job with a meaning? Become part of medac’s internationally growing team, and let’s make a difference together. We are looking forward to receiving your online application!
We want everyone to feel included and welcome, and we treat everyone equally. We welcome all applications, regardless of age, gender, personal identity, nationality, religion, ideology, ethnic and social background or disability. Anyone who is part of medac is part of a diverse - and therefore strong - team.
Do you have any questions?
Then contact our recruiting team:
Miriam Julia Anderson
Recruiting Manager
+49 4103 8006-8979
email
