Description:
In this role you will:
- QMS Policies, Processes & Guidelines Impact Assessments: Lead the development of a standardized global quality plans, policies, processes, and systems that supports the simplification agenda and ensures continued compliance with external and internal regulatory requirements.
- SOP Governance and Harmonization: Ensure governance, oversight, and harmonization of all SOPs and regulated documents.
- Audits, Deviations, CAPA Management: Represent R&D Engineering Services during internal and external regulatory inspections. Provide consultation and oversight to audit preparation and responses as well as Deviations and CAPA. Successfully lead complex regional/global deviations and CAPAs.
- Compliance Risk Assessments & Regulatory Trends: Perform Compliance Assessments for R&D Engineering Services as well as new sites that will participate in the global facilities service delivery model. Must stay abreast of industry regulatory trends.
- Quality Systems - System/Business Owner and SME for all compliance platforms (Veeva Docs, VQMS, myLearning, etc). As SME, responsible for training users and leading continuous improvement efforts.
- Lead and represent R&D Engineering Services in validation efforts ensuring that effort is scalable to risk and in accordance with the global validation master plan(s). Ensure that Service Partner implementation is consistent with GSK’s QMS and corporate policies.
Why you?
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- Holds degree in Business, Science or Engineering
- Strong experience with regulated environments (i.e., GxP)
- Strong experience working with regulatory requirements for FDA, MHRA, and other statutory regulations (local and trans-national) within pharmaceutical, manufacturing, or other large, regulated industry.
- Experience leading and supporting audit preparation and response from internal and external audit groups.