GSC R&D Engineering Services provides Facilities Management and Capital Projects delivery for Technical R&D sites within GSC’s Engineering and EHS organization.

The purpose of this role is to ensure the consistent delivery of facilities and engineering services to R&D sites globally, working to ensure cost, quality and compliance metrics are achieved by key contract partners.

The Associate Director Risk & Compliance ensures that GSK’s significant and enterprise risks are managed appropriately by the R&D Engineering Services organization and that local ways of working are in accordance with Corporate Policies, QMS (Quality Management System) Policies and Corporate Compliance programs (i.e. Risk Management, Info Protect, Data Privacy, ABAC, Third Party Oversight). The role must not only ensure that the strategies for implementation are effective but also verify through the Internal Control Framework assessment process to ensure no residual risk remains.

This role will foster a culture of transparency and trust with operations teams, service partners and customers with being present a minimum of 3 days on site per week.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

Key Responsibilities

• Inform and influence the development of an effective Quality Management System and corporate compliance program that ensures alignment of the R&D Engineering Services organization’s service delivery with regulatory requirements and GSK values. Ensure global alignment and capability that is ‘fit-for-purpose’ as other directorates, regions, and sites participate in the global facilities service delivery model, e.g. GSC Manufacturing Sites, Vaccines R&D Sites.
• 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, Change Control: 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. Author and/or inform development of GxP and non-GxP change controls.
• 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.
• Develop Training programs and report on mandatory training completion
• Develop and deploy GxP and non-GxP Management Monitoring programs
• Facilitate global Risk Management Compliance Board and Quality Council
• Develop Compliance Improvement plan and annual Quality Plans
• 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.
• Ensure that Service Partner implementation is consistent with GSK’s QMS and corporate policies.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in business, Science or Engineering
• 5+ years’ experience with regulated GxP environments
• 5+ years’ experience working with regulatory requirements for FDA, MHRA, and other statutory regulations (local and trans-national) within pharmaceutical, manufacturing, or other large, regulated industry.
• 3+ years’ experience leading and supporting audit preparation and response from internal and external audit groups.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Practical working knowledge of computer systems, processes, and documentation required to support regulatory compliance in a Life Sciences company.
• Skills as an end-to-end service owner in a highly regulated, multi-cultural environment.
• Understanding of R&D site operations
• Knowledge of compliance requirements for Facilities and/or Engineering operations
• Experience with global alignment of policies incorporating strategic and innovative thinking while providing an efficient, non-bureaucratic approach to achieve compliance.
• Ability to establish strong working relationships with key external contrac