Clinical Quality Assurance Manager, Open to flexibility

London, Stockley Park, Stevenage, Hertfordshire
14 Sep 2017
21 Sep 2017
Contract Type

Clinical Quality Assurance Manager, Open to flexibility

GlaxoSmithKline (GSK) is one of the world's leading research-based pharmaceutical companies. Our powerful combination of skills and resources provide the platform for delivering strong growth and the platform for responding quickly to the rapidly changing global healthcare environment. We are a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. We have a significant global presence with commercial operations in more than 150 markets, a network of 86 manufacturing sites in 36 countries and large R&D centres in the UK, USA, Spain, Belgium and China.

We are currently recruiting a Clinical Quality Assurance to be based in Stevenage, Hertfordshire or Stockley Park, London.

The successful candidate will be involved with a diverse range of activities including:

  • Independently plan, lead, and conduct routine and complex CQA assessments of GSK studies, systems, external vendors and GSK Operating Companies to assure compliance with GCPs and GSK policies and procedures, and applicable local regulations.
  • Effectively document assessment findings in an assessment report and obtain responses in a timely fashion.
  • Report and present to clinical development staff, clinical investigators and contract research organisation staff findings from assessments and give advice on resolving issues identified.
  • Generate and provide metrics, status and trend reports and other information, as required by management.
  • Partner with CQA Management to develop, implement and assess clinical quality assurance strategies, organisational and operational needs.
  • Act as a consultant and represent department to clinical development staff and teams in relation to compliance, quality improvement, business redesign initiatives and risk assessment.
  • Provide expert advice in relation to obtaining compliance, quality improvement, process and program initiatives and risk assessment and act as point of contact for customers and CQA staff.
  • Maintain an up to date and in depth knowledge of appropriate national and international GCP legislation and guidelines; and the impact to assigned business area processes and procedures.
  • Educate, guide and influence GSK management and staff on best quality and compliance policy and practices, especially as they relate to areas of identified responsibility
  • Assist in developing and maintaining customer training programmes and help deliver training within area of expertise.
  • Work independently and as a member of assigned CQA team.
  • Build and maintain beneficial working relationships with all internal and external customers.
  • Lead local and international GxP and process improvement projects by providing CQA input, especially on areas of responsibility.
  • Deputise for manager and take on delegated duties as required.
  • Support the recruitment of new CQA staff.
  • Manage/Champion and participate in other projects or duties assigned by the CQA management specific to CQA teams accountabilities.

Closing date for applications: Thursday 21st September 2017.

Thank you for your interest in this opportunity.

You may apply for this position online by clicking the 'Apply' button.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorisation before referring any candidates to GSK. The obtaining of prior written authorisation is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorisation being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.