Quality Manager R&D Compliance, Open to flexibility

Weybridge, Surrey
29 Aug 2018
28 Sep 2018
Contract Type

Quality Manager R&D Compliance, Open to flexibility

The role provides oversight and assurance to management for the level of compliance of CHR&D sites and vendors through the assessment processes. The role also provides support for CHR&D projects, training and ensures that CHR&D sites and vendors are inspection / audit ready.
Plans and conducts global audits independently or as a team in a lead or support role to ensure that robust processes are fully developed to meet the requirements of Good Manufacturing Practices (GMP's).

  • Lead audits of Consumer Healthcare R&D(CHRD) facilities & processes and vendors. Ensure that senior management is apprised of identified key risks together with their root causes and that appropriate corrective and preventative action plans are prepared and implemented.
  • Lead or assist management in performing of risk assessments, planning, co-ordination and conducting of complex assessments.
  • Maintain information in GSK audit database system and perform trending / analysis of Findings and Corrective Actions and Preventative Actions (CAPA's).
  • Review and assess corrective and preventative action plans and ensure timely closure of CAPA's as per GSK policies and procedures.
  • Ensure CHRD sites and vendors are inspection ready, and assist CHRD management in hosting and supporting Regulatory agency inspections at CHRD facilities.
  • Maintain current awareness of the GSK organization, its expectations and strategic direction.
  • Represent and promote CHRD Quality both internally and externally through interactions with regulatory agencies, external auditors, professional bodies and associations and customers.
  • Build effective working relationships with customers
  • Proactively engage in implementing continuous improvement activities within CHRD.
  • Lead or participate in the design and development of departmental or global processes
  • Maintain current awareness and knowledge of global regulatory requirements, GSK QMS and CH SOPs, and ensure CHRD procedures meets appropriate regulatory requirements.
  • Organise and implement training of CHRD Quality and CHRD staff for awareness of current regulatory requirements including regulatory expectations, inspection readiness and/or GSK corporate expectations.
  • Provide training to other CHRD Compliance staff in assessment processes including planning, conducting, analysing and reporting assessments as required.
  • Represent CHRD Quality at the Quality Council (QC) meetings or Projects as required.

Why You?

Basic qualifications:

10 years of pharmaceutical industry experience with at least 3 to 5 years in GMP auditing. Working knowledge of applicable GMP regulations including Medical Devices and associated guidelines.

Preferred qualifications:

  • GxP Auditor Certification from an accredited agency or GSK sanctioned recognised authority
  • Working knowledge of applicable GMP and Regulatory Affairs regulations and guidelines
  • Experience working in global and multidisciplinary environments
  • Must be IT systems literate (MS Word, Excel, & Power Point) and be familiar with audit tracking systems (e.g., Trackwise) and regulatory submission management submissions
  • Willingness to travel worldwide, sometimes at short notice

Why GSK?:


Contact information:
You may apply for this position online by selecting the Apply now button.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Similar jobs

Similar jobs