Senior Manager - IT Risk & Compliance

Senior Manager - IT Risk & Compliance

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.

With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge, and expertise, we’re uniquely placed to do this and to grow a strong, successful business.

This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.

About the role

The role Quality & Compliance Expert is responsible for providing management and day to day support to the Service Assurance & Operations Lead activities across the assigned product tower ensuring that Tech risks & controls from project inception to support are identified, prioritized, effectively managed, and monitored. Additionally, this role should work within the product tower to ensure Tech follows the required internal and external compliance standards and delivers a reduction in the overall risk profile for our customers.

This role description forms a generic outline of the Quality & Compliance Expert role. Activities could encompass some, but not all elements and may focus on areas, e.g., Programme rather than Operations. The Quality & Compliance Expert may support one or more Tech Product Towers.

Key responsibilities

• Contribute to identification and initiation of Risk mitigation projects to address significant risks impacting a product tower, using Smart Controls assessments.

• Facilitate risk identification and risk discussions within the business unit, both operational risk, product/project, and strategic risk.

• Contribute to maintenance of the product tower delivery and operational frameworks (Activities, deliverables, roles, and responsibilities) and ensure alignment to IT Management System (ITMS).

• Monitor deliverable quality, ensure quality standards are being met for products/ projects, programmes, or operations within their remit, following a risk-based approach, according to ITMS, Smart Controls assessments, local SOPs, and projects PQPs.

• Execute relevant self-inspection programmes within remit through Management monitoring and Independent Business monitoring where required.

• Support implementation of relevant Management monitoring programmes in product tower for processes not owned by GRC.

• Contribute to ensuring product tower is ready to host external inspections from regulatory bodies (FDA, EMEA, tax authorities, external (Deloitte/KPMG) and internal auditors (A&A, eCompliance)

• Support management of overall product tower inspection readiness activities and Corrective and Preventative Actions (CAPAs) in liaison with the business.

• Work with the GRC GxP lead/Controls owners and ITMS team to review and approve the policy, standards, procedures, guidance, and training for compliance with relevant legislation and Haleon Requirements

• Support reviews of the information systems for compliance with legislation and specifies any required changes within their product tower.

Qualifications and skills

• Minimum of 8-12 years’ experience in a combination of Risk Management, Quality Assurance and Compliance function in a Pharmaceutical/Consumer Healthcare environment.

• Good understanding of emerging technology risks e.g. cloud (SAAS, PAAS and IAAS), Automation etc.

• Knowledge of Tech support processes, such as ITIL

• Awareness of the regulatory trends within the Consumer Health industry including: Cyber – NIST, CSA, Information security standards (e.g. ISO27001), GxP – FDA, Code of Federal Regulations Title 21 Part 210 (Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs) & 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals) and MHRA - rules and guidance for pharmaceutical distributors, Sox – Sarbanes Oxley Act of 2002, Privacy – EDPB guidelines (Data Protection by Design and by Default), GDPR

Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/
At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. 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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Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.
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, Haleon may be required to capture and report expenses Haleon 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 Haleon’s compliance to all federal and state US Transparency requirements.