Quality Assurance (QA) Manager

A QA Manager is required by a growing pharmaceutical CRO in Hertfordshire.

Depending on qualifications and experience a deputy position, reporting to our QA Consultant, may be considered initially.

Main responsibilities:

· Manage, shape and embed a Quality culture in a rapidly developing organisation

· Develop the overall Quality philosophy in the organization

· Maintain and advance the Quality Management System, policies and SOPs covering pre-clinical and clinical development (GxP)

• Lead and manage the audit programme for GLP and GCP for Laboratories


• Perform laboratory and facility inspections and audit final reports for GxP and SOP compliance


• Review agreements (e.g. Master Services Agreements with CROs, etc.) for Quality Assurance inputs required for the execution of the agreement.


· Manage appropriate CAPA systems to ensure all Quality issues are managed through to completion

· Development of QA Unit -related SOPs and other critical and essential facility documentation

· Support the writing of policies and SOPs in collaboration with colleagues across the organisation to ensure all company's activities remain in compliance

· Manage Quality Oversight of external vendors

· Enable the organisation to be inspection and audit-ready at all times

· Host client and regulatory inspections

· Keep abreast of changes to global regulations and guidance documents


• Relevant scientific qualifications


• Significant Quality background gained within the pharma or biotech industries


• Substantial experience in Quality Assurance, ideally for GLP and GCP in laboratories, although this could be from auditing, process improvement or Quality Assurance management roles


• GxP Regulatory Inspection experience is desirable


• Leadership experience, ideally with line management responsibility


• Must have understanding of GLP landscape


The role could be full, or part-time, depending on the candidate. It is anticipated that the role would evolve as the company grows. A full-time role would initially include additional responsibilities.

· Act as company archivist,
• GLP Quality assurance: 2 years (required)