RISK & COMPLIANCE MANAGER (us)

Site Name: USA - Pennsylvania - Upper Providence, Philadelphia Walnut Street, USA - Massachusetts - Cambridge, USA - Pennsylvania - King of Prussia

Posted Date: Apr 8 2024

Posting close date is May 3, 2024

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 Risk & Compliance Manager ensures that GSK's principle 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 (Risk Management, Info Protect, 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: 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?

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 environments (i.e., GxP)
• 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 contract partners, to deliver appropriate site services in agreement with established contracts.
• High level of personal integrity with ability to handle confidential information.
• Acts as a role model for applying standards to ensure compliance.

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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