Associate Director of Quality Assurance - Biotech - Oxford

We are currently partnering with a clinical-stage Biotechnology company based in Oxford who are looking for an Associate Director of Quality Assurance. The main purpose of the role is to ensure the highest quality standards are in place and embedded within the organisation and are adhered to at all times.The role holder will ensure compliance with GCP and other relevant GxP guidance compliant with the relevant GxP guidelines, national and international regulations ensuring that the organisation is always ‘inspection ready’.

LOCATION: Oxford

Role and Responsibilities

QMS Accountabilities

• Responsible for the quality management system (QMS) ensuring it is up to date and fully compliant with GCP guidelines and international regulations.
• Responsible for reviewing and documenting QA approval of procedural documents before issuing
• Support clinical product development programmes by attendance at project team meetings and providing quality inputs related to the execution of the programmes in line with business needs.
• Lead all clinical quality matters leading to regulatory submission, clinical protocols, conduct of clinical trials and their reporting, according to all regulatory and GCP standards.
• Lead the implementation of new initiatives across the quality function to ensure consistency, compliance and business efficiencies
• Review and manage quality events, OOS, audit non-conformances, CAPAs, validation reports, quality agreements, technical agreements for compliance and completeness

Quality Oversight & Monitoring

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• Contribute to the selection and ongoing auditing of key suppliers, vendors and CROs as required.
• Act as quality lead for regulatory inspections.
• Drive the development and execution of the internal GCP Audit Programme and conduct audits including internal system, vendors, and investigator sites.
• Verification of the implementation and effectiveness of CAPA

Subject Matter Expert

• Provide consultation and direction on quality assurance and GCP compliance questions from supported functions.
• Ensure key internal stakeholders are fully aware and of requirements for QMS and support them in ensuring they are compliant.
• Provide internal training on quality systems, procedures related to GCP activities and act as the key point of contact internally for any associated queries.

For further information please get in touch with Natalie Jones via natalie@linkfieldgroup.com or call 02071835059