Quality Assurance Manager GCP (m/f/d)
Headquarter - Wedel: 29.01.2025
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.
Your tasks
Supports the responsible management in strategic planning and decision making
Identifies compliance gaps, potential or actual, as well as options for compliant outcomes and risk mitigation and drives implementation across functional areas
Consults and gives direction on quality assurance and GCP compliance questions from all functional areas involved in clinical trials
Conducts investigational site, vendor, system and process audits
Prepares and supports clinical trial teams and investigational sites before, during, and after regulatory inspections
Assists and represents 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.
At least 3 – 5 years experience of 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 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 organization to accomplish deliverables and meet quality standards
Excellent written and verbal communication skills in English and German
Willingness to travel 10 – 15 %
Are you looking for a new professional challenge and a job with a meaning?
We are a strong community of exceptional people from different countries, with diverse backgrounds, strengths and talents, united by our deep motivation to make a difference in healthcare. As an employer, it is our firm belief that by connecting, we can achieve more. And we are dedicated to providing an environment in which each and every member of our community feels valued and has equal opportunities for success and growth – regardless of where they come from, what they think or what they believe. At medac, we are committed to diversity, equality and inclusion in the workplace.