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We have partnered with a global pharmaceutical company who are now looking for a Senior Director based in the South East. As the Senior Director you will have overall responsibility for the Quality function, including Quality Assurance and Regulatory Affairs, ensuring that products meet all the necessary requirements.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Director will be varied however the key duties and responsibilities are as follows:
1. You will work with the Senior Leadership Team to provide strategic direction within the Quality unit. This will require you to direct the Quality Assurance team, culture and systems to ensure that worldwide governing body regulations are adhered to.
2. You will have oversight of the Quality System maintenance and improvement, for both developmental and commercial products.
3. As the Senior Director, you will develop the Regulatory Affairs structure, ensuring that all global areas have a robust structure in place. You will manage all MA's, ensuring these are achieved and maintained.
4. You will chair Quality meetings, ensuring that the strategic direction is implemented throughout the business and that objectives are known and consistently hit. You will report findings and KPI's to the Senior Leadership Team, advising on the growth of the Quality units.
To be successful in your application to this exciting opportunity as the Senior Director we are looking to identify the following on your profile and past history:
1. You will have previously held a Senior Management or above position, leading a Quality unit within a pharmaceutical or life science business.
2. As the Senior Director, you will have worked with varying global regulatory agencies, including the MHRA, EMA, FDA and CFDA, hosting audits and inspections.
3. A working knowledge and practical experience working with GxP regulations.
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