Job Reference: J5634722
Updated On: 18/05/2021
Status: Now Interviewing
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Role OverviewWe are currently looking for a Quality Director to join a leading pharmaceutical company based in the Merseyside area. As the Quality Director you will be responsible for developing and driving the direction of the Quality standards and culture for the site, alongside having the oversight of all Quality aspects of site production, including MHRA and FDA audits.
Key Duties and ResponsibilitiesYour duties as the Quality Director will be varied however the key duties and responsibilities are as follows:
1. You will work closely with the Site Lead in developing and driving a world class Quality Culture. As the Quality Director, you will lead the improvement of all Quality standards, Culture and Strategies.
2. As the Quality Director, you will provide the necessary QA functions for the site. This will include Operational Quality, Quality Systems, Batch Release duties and leading interactions with regulatory bodies, including the FDA and MHRA.
3. You will be responsible for ensuring that products are manufactured and released in compliance with marketing authorisation requirements and GMP.
4. You will provide the SLT with an overview of current Quality standards, regulations, remediation projects and any other Quality related issues.
Role RequirementsTo be successful in your application to this exciting opportunity as the QA Director we are looking to identify the following on your profile and past history:
1. You will have previously managed and lead a Quality Assurance function, within a pharmaceutical or biotech company
2. Qualified Person (QP) status is desirable.
3. A working knowledge and practical experience with regulatory bodies such as MHRA and FDA
Key Words: Quality Director | QA | Quality Assurance | Head of Quality | Strategic | Leadership | Site Lead | QMS | QP | Qualified Person | Release | MHRA | FDA
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