Reporting to the Director of Quality, the QMS and Compliance Lead will assist in the delivery of autonomous and innovative leadership to achieve the following:
Delivery of compliant Quality Systems, and development of a world-class QMS, through effective leadership of the QMS and Compliance teams;
Effective and swift development of health interventions, and increase the Company’s competitive edge in translational research;
Delivery of a leading, discrete, and complex business, to meet the needs of the Company’s ongoing future strategy;
Further enhancement of the Company’s good reputation with all relevant stakeholders and sectors;
Reduction in regulatory obstacles through application of new technologies and an effective and motivated workforce;
Improvement of current levels of grant and other income;
Delivery of the strategic direction, and business objectives, of the Company;
Taking full responsibility of Quality Systems (including GxP).
Primary Duties & Responsibilities:
•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
In order to be considered for this permanent position you do need to have the following experience:
Extensive experience in the pharmaceutical or biotech industry with extensive GMP QA experience within the FDA and/or EMA regulated environment
Proven experience of GMP QA management of a team of QA professionals
Comprehensive working knowledge of local, state, federal and international cGMP regulations; FDA/EU/ICH guidelines; validation standards, QMS and quality risk management principles
Proven experience with leading and hosting successful regulatory agency inspections
Programme and project management Service delivery and improvement Communication and stakeholder relations;
Excellent verbal and written communication skills;
Ability to effectively collaborate in a dynamic environment;
Self-motivated and able to prioritize projects in a fast-paced environment;
Ability to influence and motivate others towards compliance at all levels
Please make your interest known to our lead consultant Louise Howard who will be more than happy to discuss your application.