Hobson Prior are currently recruiting for a Head of Quality to join a leading biopharmaceutical organisation in London to implement and maintain an effective quality assurance system. Our client is focused on providing innovative therapies to patients with life limiting rare illnesses.

Job Responsibilities:

• Responsible to establish and maintain quality management system repository and framework, covering all GCP and GMP aspects of the Company's operations.
• Ensuring implementation of Policies and Standard Operating Procedures for all aspects of GXP operations and GXP supporting systems, in collaboration with the relevant process owners.
• Recognise and support proactive GXP risk management in key risk areas, in collaboration with key stakeholders in the Company.
• Define and maintain all aspects of the audit programme including, but not limited to; maintenance of the audit cycle, definition of the annual audit schedule, planning, conducting, reporting and follow up of audits (internal and vendor), oversight of audits contracted to consultants.
• Establish and maintain the Quality Assurance / Quality Management (QA / QM) repository to support oversight of Quality within the organisation (audits, vendor oversight, quality issues [deviations, complaints etc.] change controls).
• Directly line managing permanent QA staff and oversight of QA Consultants/vendors.
• Implementation of GCP, GMP and related compliance and quality training (internally or externally sourced as appropriate).
• Collaborating with the Head of IT and System Owners to ensure appropriate validation of regulated systems and controls.
• Collaboration with the Head of Pharmaceutical Development, Head of Clinical Operations and Chief Medical Officer to ensure ongoing quality support for all GXP operations.
• Production of annual quality report.

Key Skills:

• Strong risk and change management skills.
• Strong process mapping and development skills.

Requirements:

• Minimum Bachelors' Degree (preferably scientific discipline).
• Must have strong GCP and GMP experience plus experience of other GXPs.
• Overall Quality Assurance System Maintenance and ability to define and drive quality strategy.
• Minimum 5 years' auditing experience, primarily vendor and trial site auditing.
• Strong in management of Quality Issues (CAPAs, Deviations, Complaints).
• Strong experience in management of change control system.
• Willingness to travel.
• Previous experience of regulatory inspections.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.