Reference: 09052 Job Type: Permanent Date Posted: 7 May 2021
Job Type: Permanent
Date Posted: 7 May 2021
A global biotechnology company who are a market leader in their therapeutic area are looking for a Senior Quality Manager to join their team in Germany.
As a key member of the Quality Assurance team, you will ensure compliance of quality regulations and procedures for cell and gene therapies for a pioneering business at the forefront of scientific innovation. As a Responsible Person, you will be working within a business which gives plenty of scope for innovation and challenge.
- Establish a Quality Management System to ensure GDP and GMP requirements are in place to apply for a Wholesale Dealers Authorisation (WDA) as well as Advanced Therapy Medicinal Products (ATMP)
- Act as a Responsible Person per GMP and GDP requirements
- Ensure QMS is implemented and maintained on all sites
- Manage CAPAs and post inspections
- Oversee and approve Standard Operating Procedures as well as any other Quality documents
- Take the lead on Regulatory Inspections relating to GDP and GMP guidelines
- Ensure all national quality requirements are followed
- Previous experience in an operational quality role particularly in the pharmaceutical setting
- Educated to degree level in a scientific field
- Responsible Person in the EU
- Extensive experience in Quality Assurance in a pharmaceutical setting
- Great understanding of GDP and GMP guidelines
- Excellent knowledge of global regulatory inspections
- Excellent leadership and communication skills
Park Street People Ltd does not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and complies with all relevant UK legislation. We are acting as an Employment Agency in relation to this role.
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