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Head of Regulatory Affairs

4 months ago

Dunstable Bedfordshire, United Kingdom Real Full time

Our client is an established pharmaceutical company engaged in the development, manufacture, marketing and distribution of generic medicines in the UK and Europe.
They offer a wide range of high-quality medicines to the healthcare sector, that optimises cost efficiencies whilst ensuring reliable supply. They are now looking to hire a Site Head of Quality to lead the Quality Assurance activities at one of the company sites.
The site Head of Quality will lead the designated site in terms of GMDP quality and compliance, including in the areas of: QA, QC, GMP, GDP, QP activities and RP activities in line with the business goals and plan.
Deliver a weekly report, in conjunction with the Site Director, communicating areas of challenge, delivery and risk
Lead and demonstrate a continuous improvement mindset (e.g. lean, six sigma etc.)
Plan to have a deputy, capable of supporting robust operations, including when senior staff are absent or unavailable
Lead on Governance, Quality and H&S and Environmental matters
Risk governance processes, looking at understanding and proactively managing site risk
Establish/Improve on metrics, to demonstrate and understand changes in the performance of the site, in terms of ComplianceDuties:
Lead regulatory inspections, linked to GMDP, H&S
Support the building of a high-capability and high-delivery team, linked compliance, with the Company HR team
Life Sciences - Pharmaceutical manufacture and Distribution
Quality Assurance Management of site level activities
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