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Head of QA

Posted 18/08/2021
£75,000 per annum
Full time

Head of QA
37.5 hours per week
Salary Circa £75,000 DOE

Company information:

Company client is a medium sized life-science company performing a range development and manufacturing roles for biopharmaceuticals. This also includes all associated support functions from logistics through to engineering, quality control / quality assurance, regulatory affairs, and management. The Company manufactures two licensed products, Erwinase and the UK’s Anthrax Vaccine as well as providing R&D services for product development.

Key responsibilities, but not limited to:

·        Lead the QMS & Compliance teams to deliver compliant Quality systems, and develop a world-class QMS;
·        Provide operational direction and leadership to a large team of GMP Quality professionals, Documentation control, & Archivist staff;
·        Develop and manage the QA, GMP, & QMS programmes, policies, standards, and procedures to ensure conformance to the highest standards and regulatory agency requirements (MHRA, EU, FDA etc.);
·        Establish processes and systems that support collaboration, compliance and are simple and effective;
·        Lead and support where required with regulatory inspections;
·        Further develop, implement and manage processes that align with, and drive, effective systems for change control, deviations and investigations, complaints, recalls, risk management and CAPA;
·        Oversee GMP Quality system performance metrics, analyse compliance data and coordinate the necessary Quality reporting and escalation responses;
·        Manage the processes for the Quality Management Review Board, Change Control Review Board and Risk Management forums;
·        Provide expertise and guidance to senior management in the interpretation of global GMP regulations, ICH guidelines and internal policies and procedures;
·        Promote continuous improvements in quality systems and department infrastructure; assist with creation/revision of appropriate SOPs, Code of Practices, Policies & Key Quality documents;
·        Train, manage, and mentor QMS, GMP, & QA staff for the effective performance in PBL cGMP processes & compliance activities

 Person Specification:
·        Have current right to work in the UK;
·        A good standard of written and spoken English language
·        Practical Understanding and working knowledge of GMP regulations & compliance requirements
·        Extensive experience in the pharmaceutical or biotech industry with extensive GMP QA experience within the FDA and/or EMA regulated environment
·        Experience of GMP QA management of a team of QA professionals
·        Comprehensive working knowledge of local, state, federal and international cGMP regulations
·        Ability to influence and motivate others
·        Strong communication skills at all levels
·        Attention to detail

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