Job Posted: 19 Jan 2017

**Associate Director GCP / PV Audits and Inspections - South East UK**

Excellent Salary + Package| Cambridgeshire| Permanent

A well known and exciting Global pharmaceutical company is actively looking for an Associate Director of GCP/PV Quality Auditing and Inspections to join their team, based in Cambridge. This role will require a professional who can demonstrate strengths in GCP Auditing and Inspections, and ideally team that with PV QA expertise as well! The role will give a Manager/Senior Manager or current Associate Director the chance to join a company where progression is clearly outlined, and common.

 

Requirements:

We are now looking to hire an Associate Director for the Science Units Audit & Inspection team.

The QA department is part of the Global Medicines Development organisation which drives late-stage development of the innovative pipeline. This role, in particular, will work across early to late stage development across all Science Units within the company.

As an Associate Director for Audit & Inspections you will get the opportunity to lead execution of clinical and pharmacovigilance quality assurance audits for the Science Unit quality and compliance program. You will be responsible for evaluation of risk, standards and quality principles. You will also manage and facilitate regulatory inspections.

If you have a sound understanding of Good Clinical Practice (GCP) and/or Good Pharmacovigilance Practice (GPvP) guidelines and regulations, along with experience in carrying out and leading audits, this is a fantastically unique opportunity for you to join this organisation.

 

Main Duties and Responsibilities

  • Implements effective GCP and/or GPvP compliance program activities; travel up to 25% expected
  • Leads or participates in global GCP and GPvP audits
  • Works with contract personnel or consultants to prepare, conduct and report assurance audits
  • Facilitates the development of CAPAs / risk mitigation plans
  • Participates in preparation for and management of regulatory authority inspections
  • Leads the development and/or revision of QA processes and procedures including SOPs and risk assessment tools
  • Act as trainer and mentor for GCP and/or GPvP Auditors
  • Communicates effectively with compliance colleagues and customers and maintains robust knowledge of relevant industry information affecting compliance arena
  • Support driving and embedding a culture of ethics and integrity

 

Requirements

  • Degree level education
  • Established GCP / GPvP QA professional
  • Knowledge of corporate governance, health care regulations, laws and standards
  • Excellent analytical, written and oral communications skills
  • Strong collaborative, partnering, and interpersonal skills
  • Strong ability to work independently
  • High ethical standards, trustworthy, operating with absolute discretion

Desirable

  • Experience supporting regulatory authority inspections

 

For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest!

 

Sam Caley - Advanced Clinical Recruitment

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LinkedIn Search: Sam Caley Quality Assurance

 

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