Senior Quality Assurance Manager - Biotechnology Company - Oxfor
|Area||M4 Corridor, UK|
|Sector||Pharma / Biotech|
|Salary||£ 60,000 ~ 70,000 Competitive|
We are currently partnering with a clinical-stage Biotechnology company based in Oxford who are looking for a Senior Quality Manager. 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 we are fully legally compliant and compliant with the relevant GxP guidelines, national and international regulations ensuring that the organisation is ‘inspection ready’ at all times.
- Responsible for the quality management system (QMS) ensuring it is up to date and fully compliant with GXP guidelines and international regulations.
- Responsible for reviewing and documenting QA approval of procedural documents before issue as company policies
- Supporting clinical product development programmes by attendance at project team meetings and providing quality inputs related to execution of the programmes in line with business needs.
- Contribute to 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 quality events, OOS, audit non-conformances, CAPAs, validation reports, quality agreements, technical agreements for compliance and completeness
- Lead the investigation of quality events and root cause analysis and review their conclusions and recommendations
- Provide quality support in assessing requirement of validation, designing and approving validation protocols, participate in execution of these protocols
- Contribute to the selection and ongoing auditing of key suppliers, vendors and CROs as required.
- Act as a key support for any MHRA audits (eg GCP, PV) and FDA audits, when they arise.
- Driving the development and execution of the Company GXP Audit Programme and conduct GXP audits including internal system audits, vendor audits, and investigator site audits.
- Managing, reviewing and finalising responses to audit reports in collaboration with relevant staff.
- Managing CAPA process, issuing escalation and change management, derived from internal and external audits until closure.
- Keep up to date and maintain an ongoing awareness of changes in legislation, regulatory requirements and business policies regarding QMS and GxP.
- Must hold a Batchelors degree in a scientific/healthcare field
- Significant experience of Quality Management in a GxP related biotech or pharmaceutical company including maintaining and developing a QMS to support all clinical activities.
- Understanding and wide experience of GCP/ICH and clinical quality requirements/standards is essential for this role.
For further information please get in touch with Natalie Jones via firstname.lastname@example.org or call 02071835059