Head of QA

Highly Competitive
  1. Permanent
  2. Senior/Director & VP
  3. United Kingdom
Crawley, England
Posting date: 21 Jan 2021

A large full service Contract Research Organisation is in search of a QA Manager to direct and lead the entire Quality Assurance program in both US and UK locations.

Job Responsibilities

  • Partners with internal and global external clients to manage a best-in-class GCP Quality Assurance (QA) program which enhances the organization's capabilities and continued growth.
  • Oversees Quality Assurance team by providing guidance and direction to ensure departmental and client/project goals are met; coaches and develops team members.
  • Manages the global GXP QA process and implements QA initiatives/audit programs, including IT QA projects, all of which lead to continuous improvement.
  • Manages the corrective/preventive action plan (CAPA) process to ensure timely implementation of CAPAs, and escalation, as applicable.
  • Conducts GXP audits of company systems, CRAs, clinical sites, external vendors and GMP audits as needed and ensures appropriate follow-up.
  • Develops and leads audit /inspection readiness activities to ensure staff members are prepared to proactively participate in regulatory inspections and audits, and appropriately address outcomes.
  • Assists in facilitation of client audits and regulatory inspections.
  • Oversees quality system which provides guidance, tracking, and metrics of compliance.
  • Oversees the SOP development process and compliance.
  • Leads all training programs & initiatives while also administrating electronic training database

Skills and Requirements

  • Minimum of a BA/BS in Science required.
  • Advanced degree preferred.Prior experience leading GCP Quality Assurance programs and interfacing with the FDA & EMA.
  • International and oncology experience preferred.
  • Management experience, 7+ years in a CRO/pharmaceutical environment, is required.
  • Effective ability to meet short- and long-term goals.
  • Effective ability to anticipate challenges and to develop and implement solutions.
  • Effective knowledge of MS Office computer skills.
  • The ability and willingness to travel as required in the US and Internationally.

To Apply

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