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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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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