Site Head of Quality Assurance (PR/266253) Dunstable, England
Salary: GBP80000 - GBP110000 per annum + benefits
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 optimise cost efficiency whilst ensuring reliable supply. They are now looking to hire a Site Head of Quality Assurance for this site in Bedfordshire.
The Head of Quality Assurance will lead the designated site in terms of compliance, including in the areas of: QA, QC, GMP, GDP activities, and RP activities.
Responsibilities:
* Establish clear and compliant GMP/GDP standards for all site activities
* Align with the broader organisation to ensure uniform high standards
* Share best practices for the benefit of the organisation in relation to QA
* Establish a clear site-level governance process, feeding the organisation committee
* Deliver clear and concise scorecards on a weekly basis in conjunction with the Site Director, including status and progress
* Deliver a weekly report with the Site Director, communicating areas of challenge, delivery, and risk
* Escalate issues of significance in a timely manner at site level and beyond
* Lead and demonstrate a continuous improvement mindset (e.g., lean, six sigma, etc.)
* Plan to have a deputy capable of supporting operations during senior staff absences
* Lead on Governance, Quality, H&S, and Environmental matters
* Implement independent audit systems for internal audits of relevant departments
* Manage risk governance processes, focusing on understanding and proactively managing site risk
* Establish/Improve on metrics to demonstrate and understand changes in site compliance performance
Duties:
* Lead the site Compliance Council process
* Lead regulatory inspections linked to GMDP, H&S, etc.
* Deputise for the Site Director on matters associated with Ethics and Compliance
* Build relationships with regulators that impact the site (e.g., MHRA)
* Support the building of a high-capability and high-delivery compliance team with the Company HR team
* Lead site recall activities as required
* Manage DMRC communication as required
Qualifications/Skills:
* Ideally Degree level education or a track record in a similar position
* Expertise with manufacture of Solid Dose and Generic Pharmaceuticals is required
* Quality Assurance Management expertise - team management
* QP status would be a bonus although this isn’t a deal breaker for exceptional candidates
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