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• Bachelor’s degree in related Health Science field or equivalent. An advanced degree would reduce the work related experience requirement.
• A broad scientific/pharmaceutical industry background with relevant experience in pharmaceutical research and/or pharmacovigilance.
• Previous experience of Good Clinical Practice, Good Pharmacovigilance Practice and/or Quality Assurance is preferred.
• Extensive knowledge of global, regional and national regulatory requirements and regulations.
• Detailed knowledge of the drug development and clinical processes.
• Has demonstrated ability to manage global projects and programs, which can contain regional focus/drivers in a culturally diverse organization.
• Have a demonstrated and sound working knowledge with expert understanding of the approach and perspectives of regulatory agencies.
• Demonstrated experience interacting with regulatory agencies.
• Demonstrated ability to function effectively and strategically as team member; to communicate professionally and effectively, with all levels of management and to negotiate persuasively.
• Must have a high degree of organizational awareness and working towards resolution with complex problems.
• Have demonstrated project management skills and management of cross-functional activities.
• Have demonstrated ability for excellent verbal, written and presentation skills.
• Ability and desire for frequent domestic and international travel (approximately 25-40%).
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 organization 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, organizational 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.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
Thank you for your interest in this opportunity.
You may apply for this position online by selecting the Apply now button.
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