Manager, GvP QA

Highly Competitive
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. United Kingdom
Cambridge, Cambridgeshire
Posting date: 09 Jul 2019
QA.KM.24219_1562660435

ProClinical is seeking a Manager, GVP (QA) on behalf of a specialist oncology company. This is a permanent position based in Cambridge, UK.

Job Role:

  • Responsible for supporting the development, coordination and implementation of Good Pharmacovigilance (GVP) related quality assurance activities for the Pharmacovigilance (PV) Quality Assurance (QA) function.
  • Ensure Good Pharmacovigilance Practice (GVP) within Company throughout all phases of the product development life cycle, including pre-clinical, clinical and post-marketing stages globally.
  • Responsibilities include execution of internal and external Pharmacovigilance (PV) audit programs, as well as providing support for Pharmacovigilance-focused health authority inspections.

Job Responsibilities:

  • 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
  • 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
  • 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

Education, Skills and Exprience:

  • A minimum of 5 years of relevant and increasingly responsible experience in the Biotech/ Pharmaceutical Industry, specifically within GVP and with at least 3 years in quality or compliance.
  • Experience in GVP auditing is required.
  • Bachelor's or Master's degree in a scientific or life sciences discipline or equivalent. A healthcare background is preferred.
  • Demonstrated GVP audit conduct experience is required.
  • Regulatory Knowledge - 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.
  • Industry Knowledge - 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.
  • Functional Knowledge - 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.
  • Scientific Knowledge - Possesses the necessary science education and knowledge to support QA oversight of the PV system.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Katty Maia at k.maia@proclinical.com or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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