Site Head of Quality Assurance (PR/4000529) Wingate, England
Salary: GBP90000 - 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, optimising cost efficiency whilst ensuring reliable supply. They are now looking to hire a Site Head of Quality Assurance for their site in the North East. The Site Head of Quality Assurance will lead the designated site in terms of compliance, including in the areas of: QA, QC, GMP, GDP, QP 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, in conjunction 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, including when senior staff are absent or unavailable Lead on Governance, Quality and H&S, and Environmental matters Implement independent audit systems for internal audits of relevant departments Manage risk governance processes, proactively managing site risk Establish/Improve on metrics to demonstrate and understand changes in the performance of the site in terms of Compliance 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 a relationship with the regulators that impact the site e.g. MHRA etc. Support the building of a high-capability and high-delivery team linked to compliance with the Company HR team Lead site recall activities as required Manage DMRC communication as required Qualifications/Skills: Ideally Degree level education or track record in a similar position Experience in Solid Dose and Generic Pharmaceuticals Quality Assurance Management experience Ideally QP status, although this isn’t a deal breaker
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Salary: GBP90000 - 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, optimising cost efficiency whilst ensuring reliable supply. They are now looking to hire a Site Head of Quality Assurance for their site in the North East. The Site Head of Quality Assurance will lead the designated site in terms of compliance, including in the areas of: QA, QC, GMP, GDP, QP 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, in conjunction 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, including when senior staff are absent or unavailable Lead on Governance, Quality and H&S, and Environmental matters Implement independent audit systems for internal audits of relevant departments Manage risk governance processes, proactively managing site risk Establish/Improve on metrics to demonstrate and understand changes in the performance of the site in terms of Compliance 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 a relationship with the regulators that impact the site e.g. MHRA etc. Support the building of a high-capability and high-delivery team linked to compliance with the Company HR team Lead site recall activities as required Manage DMRC communication as required Qualifications/Skills: Ideally Degree level education or track record in a similar position Experience in Solid Dose and Generic Pharmaceuticals Quality Assurance Management experience Ideally QP status, although this isn’t a deal breaker
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