GVP Quality Assurance Manager in Cambridge
Sam Whyley-Smith at CK Clinical is recruiting for a GVP QA Manager to join a Global Biotechnology company, based in their office in Cambridge on a permanent basis, with 40% travel required for the role.
The Company: Our client is a Global Biotechnology company with a robust pipeline of products in development across multiple indications in the oncology field, who are currently expanding and growing their UK based operations.
Key Responsibilities include to:
- Implement and maintain the risk-based internal and external (vendor) PV audit program, including risk strategy, tactical and operational audit planning:
- Ensure PV audits are scheduled, conducted and reported as planned.
- Ensure PV audit CAPAs are established, agreed and tracked to closure.
- Ensure PV audit metrics are prepared, analyzed and improvements instituted.
- Direct global PV inspection activities:
- Support the Director, GVP QA in preparing all necessary departments for likely PV inspections, providing support during inspections and ensuring timely responses to inspection findings are prepared, submitted and associated CAPAs tracked to closure.
- Oversee deviations impacting on PV:
- Identify and monitor deviations impacting on PV.
- Ensure CAPA resolutions are established.
- Verify effectiveness of the CAPA resolutions.
Support periodic review of PV department policies/procedures/work instructions Support review of quality systems procedures from a PV QA compliance perspective.
Liaise with other QA functions to collate, review and provide requested data and information for the PSMF, Quality Management Reviews, Annual Reports and other reports and presentations.
- Provide EU QPPV with necessary QA data allowing oversight of the PV quality system.
- Respond to general PV-QA queries and provide advice and guidance to PV Operations, QA and other functional groups in relation to PV topics.
- Monitor, analyze and communicate PV regulation, guidance and trend changes.
- Coordinate with GMP QA, GCP QA and QS colleagues ensuring harmonized quality approaches.
- Attend company, departmental and cross-functional meetings as required.
- Report to supervisor on project progress, issues, and problem solving.
- Perform other duties as assigned.
- A minimum of 5 years of relevant and increasingly responsible experience in the Biotech/Pharmaceutical Industry, specifically within GVP auditing and with at least 3 years in quality or compliance.
- Bachelor's or Master's degree in a scientific or life sciences discipline or equivalent.
- Strong working knowledge and application of global GVP regulations and guidances.
- Understands the regulatory environment for global pharmaceutical companies, as well as best practices to satisfy regulatory requirements.
- Working knowledge of the pharmaceutical industry and the new drug development process. Understands the phases, processes and techniques used to execute a clinical development program. Understands the unique business requirements of operating as a marketing authorization holder in a virtual pharmaceutical environment.
- Knowledge of and experience in quality assurance, auditing, inspection support, procedural management and quality systems (including training, deviations, corrective and preventive actions, risk management) as implemented within GVP. General awareness of GCP, GMP and GDP activities.
- Possesses the necessary science education and knowledge to support QA oversight of the PV system.
- Must professionally, clearly, concisely and consistently communicate to internal and external colleagues at all levels, both verbally and in writing. Must demonstrate effective presentation and training skills.
- Takes initiative and works well in teams and/or independently. Demonstrates proficiency in managing assigned projects, delivering expected deliverables in a timely manner, manage multiple projects while maintaining quality and proactively communicate changes in established goals and deadlines. Must prioritize work effectively to meet timelines.
- Literate in Microsoft Office Suite (MS Word, Excel and PowerPoint).
For more information or to apply for this position, please contact Sam on 01246 580040 or email on firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45999 in all correspondence.