Quality Assurance Manager- GCP and Auditing

RBW are working in partnership with an award-winning specialist CRO, who seek a Quality Assurance Manager with GCP expertise to join their friendly QA team.

They need a candidate with extensive knowledge of GCP and clinical trial legislation, outstanding auditing skills, and exceptional organisational skills. This position will suit someone working at the top end of QA Senior Specialist remit, who is looking to step up to a Manager role.

The QA Manager will be responsible for the performance of internal audits in accordance with the annual audit schedule and supporting the maintenance and continuous improvement of the QMS. They will provide expert Quality Assurance and regulatory advice to colleagues across all levels of the business, so must be an effective communicator.

Role Responsibilities:        

Quality Assurance

• Management of the Quality Management System
• Contribute to the generation and management of the internal audit schedule, conduct and report internal audits in accordance with the internal audit schedule and conduct Vendor Audits as instructed
• Lead, manage and coordinate client audits and Regulatory Inspections
• Follow up on audit reports and vendor questionnaires
• Review and QA approval of SOPs and other controlled documents
• Effectively monitor compliance to processes
• Provide input for and maintain oversight of CAPAs and Quality Issues
• Generate Quality metrics reports to provide updates to the Executive Leadership Team on quality related issues and initiatives
• Ensure company-wide compliance to EU and UK clinical trial legislation, ICH GCP and other applicable legislation

Quality Improvement:

• Promotes good practice by challenging standards within the workplace and by suggesting areas for improvement.
• Inspire and drive company to achieve and maintain quality values
• Review of lesson learned meetings, customer concerns, issues and CAPAs for quality-related items and responsibility for coordinating any resulting training or process updates

Training and Development

• Management of Staff Training Records
• Development and delivery of training materials related to quality, including GCP

Role Requirements:

• BSc or equivalent, and have at least 5 years’ experience in a Quality Assurance role performing GCP audits.
• Experience of hosting Regulatory Inspections and client audits is essential, as well as an ability to manage multiple projects at once.
• Knowledge of Computerised Systems Validation methodology and Data Protection legislation would be advantageous.

About the Company:

Our client have won awards for being one of the best mid-sized and consultancy companies to work for!  This role will be based from home, with occasional trips to the offices in London, Cheshire or Wales, for audits or social occasions.

They offer a fantastic benefits package, including:

• 25 days holiday plus bank holidays
• Additional 5 days unpaid leave
• Pension
• Private and business travel insurance
• Private healthcare
• Cycle-to-work scheme
• Season ticket loan
• Annual bonus, based on personal performance
• Death-in-service scheme,
• Employee assistance programme
• Summer and Christmas parties and other company socials.

Please move fast as this role will have a lot of interest. Apply with your CV today, or contact  katie.dunbar@rbwconsulting.com for more information.