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    risk & compliance manager (uk) - Stevenage, United Kingdom - 1054 GlaxoSmithKline Services Unlimited

    1054 GlaxoSmithKline Services Unlimited
    1054 GlaxoSmithKline Services Unlimited Stevenage, United Kingdom

    1 week ago

    Default job background
    Full time
    Description

    Risk & Compliance Manager

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

    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.

    We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programmes.

    We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

    Discover more about our company-wide benefits and life at GSK on our webpage

    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.

    • 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.

    • Preferred Qualifications & Skills:

    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.
  • 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.

    • Why GSK?

    Uniting science, technology and talent to get ahead of disease together.

    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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

    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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

    As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).

    We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

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