Compliance and Regulatory Risk Manager

4 weeks ago

Stevenage Hertfordshire, United Kingdom GlaxoSmithKline Full time

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 offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programmes.
our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
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.
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. 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.
Holds degree in Business, Science or Engineering
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.
Practical working knowledge of computer systems, processes, and documentation required to support regulatory compliance in a Life Sciences company.
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.
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).
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. recruitment@gsk.We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. 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 authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization 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.
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