Director - SN Risk & Compliance Manager

GSK remains committed to achieving bold commercial ambitions for the future. By 2031, we aim to deliver £40 billion in annual sales, leveraging our existing strong performance momentum to significantly increase our positive impact on the health of billions of patients globally. Our Ahead Together strategy is centred on early intervention to prevent and alter the course of disease, thereby protecting people and supporting healthcare systems.
Our diverse portfolio consists of vaccines, specialty medicines, and general medicines.
Through continuous innovation and a dedicated focus on scientific and technical excellence, we strive to develop and launch new, groundbreaking treatments that address critical health challenges.

Job Purpose 

The SN Risk & Compliance Manager owns the risk and compliance position of the ServiceNow and enterprise tools platform, keeping it in a state of compliance and fitness for intended use across its operational life as required by the Digital and Tech Risk-Based Integrated Software Development Lifecycle (SOP2). The role runs the Risk and Compliance Assessment that classifies platform change onto the Standard or GxP delivery track, verifies Digital Risk Navigator control attestation before release, and maintains the qualification and release evidence the platform depends on.

The platform is unusual in that it enforces controls for the rest of Digital and Tech. The GxP, SOX, CAB required, outage and electronic signature flags in ServiceNow change management, and the risk and impact questionnaire behind them, are automated controls that other teams rely on, so a defect here is systemic rather than local. Quality assurance and testing for platform change sit with the SN QA Lead, ITSM process design and governance sit with the ITSM Process and Governance Lead, product direction sits with the Product Managers and Product Owners, platform operation sits with the SN Platform Managers, and enterprise policy is set by the Governance Risk and Compliance function.

Key Responsibilities

• Own the risk and compliance position of the ServiceNow and enterprise tools platform, keeping it in a state of compliance and fitness for intended use throughout its operational life.
• Represent and support the submissions for the ServiceNow and enterprise tools platform at DPTF & D&T RMCB’s
• Run the Risk and Compliance Assessment for platform and product change, initiating it at concept phase so that Standard Track or GxP Track classification is settled before design rather than discovered at release.
• Verify Digital Risk Navigator control attestation before release, and withhold release where controls assigned by the assessment have not been implemented and evidenced.
• Assure the automated compliance controls configured in ServiceNow change management, covering the GxP, SOX, CAB required, outage and electronic signature flags and the risk and impact questionnaire that drives them.
• Assure quality and compliance approval routing, so that GxP changes and changes against configuration items with documented prior agreement reach a regulatory approver rather than closing on technical approval alone.
• Maintain platform and tool qualification evidence, and the release documentation set covering plan and operations manuals and validation summary reports for both delivery tracks.
• Run periodic compliance review for the platform, and track findings and remediation through to closure rather than to acceptance.
• Complete the AI Accountability Report with the business and technology owners for platform features using artificial intelligence or machine learning, and assess the control implications before those features are enabled.
• Assure access management and privileged operations controls for the platform, including segregation of duties, given that platform administrators can alter the controls other teams are governed by.
• Produce Management Monitoring and Internal Controls Assurance evidence for the platform's controls, so that assurance is continuous rather than assembled at audit.
• Support internal audit and regulatory inspection for the platform, act as the point of contact for platform-related findings, and assess vendor capability where the supplier's documentation or services are relied on.
• Hold the boundaries with the SN QA Lead on quality assurance and testing, the ITSM Process and Governance Lead on process design, the Snr. Technical Change Manager on the enterprise change process, and the Governance Risk and Compliance function on enterprise policy.

Education & Professional Qualifications

• Degree in a technology, life sciences, quality or business discipline, or equivalent practical experience.
• Risk, audit or validation certifications desirable (e.g., Certified Information Systems Auditor, GAMP 5 computer system validation training, or ITIL 4 Foundation).

Job Experience:

• Typically 8-10 years in IT risk, compliance, quality assurance or computer system validation, including at least three years in a regulated environment.
• Practical experience applying a risk-based software development lifecycle, including classifying change onto differentiated delivery tracks.
• Experience with computer system validation for configurable or software-as-a-service platforms, including qualification and release documentation.
• Experience assuring automated or configured controls, rather than only documenting manual ones.
• Track record supporting internal audit or regulatory inspection and taking findings through to closure.
• Working knowledge of ServiceNow or a comparable enterprise service management platform, sufficient to assess whether a control is configured as intended.
• Exposure to the control and accountability implications of artificial intelligence or machine learning features in a regulated platform.

Preferred Skills:

• Willingness to withhold a release when the evidence is not there, and to explain precisely what would satisfy the requirement.
• Precision with controlled documentation, since the record is the evidence and an inaccurate one is a finding.
• Enough platform literacy to test whether a control is genuinely configured as described rather than accepting an assurance.
• Ability to work with delivery teams as an enabler of release rather than as a gate they route around.
• Composure during audit and inspection, answering what is asked without volunteering speculation.
• Persistence on remediation after the finding has been logged and attention has moved elsewhere.

#AGTech

Skills

Why GSK?

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.

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