Job Description

Due to the increase in regulatory focus on electronic data integrity issues that emanate from regulated GxP computerised systems that impact product quality and patient safety the role will support the compliant implementation and maintenance of GxP computerised systems and data within their respective business unit.In addition, they shall support the Digital & Data Solutions Quality Lead with process improvements and provide subject matter expertise and guidance.The E-Compliance Senior Manager will possess self motivation and continuous improvement skills, as well as experience in GxP regulations, Control Frameworks and Risk Management activities, Agile/Scrum development/deployment methodologies, Tech and Business Quality, Computerised Systems Validation/Qualification and Records Management.
This role will provide support across Digital and Tech.The role is key to ensuring Tech controls are effective to handle risk through the adoption of internal and external good practice through ownership of the Tech Control Framework and IT Management system on behalf of the Digital and Tech function. This responsibility covers inclusion of all risk areas that are posed by Technology; cybersecurity, GxP, Sox, Privacy, Sanctions, AI and ESG as well as any new and emerging risks that need to be built into the framework.Provides strategy for simplified and optimized risk assessment activities as well as responsibility for compliance training for the Digital and Tech organisation.Subject matter expert in aspects of GxP risk and audit for technology, unique skillset. Solves unique regulatory and compliance related problems across a wide range of technology products and adjusts strategy and policy to ensure continual improvement. Support delivery of Computer Systems Quality.Key Roles & Responsibilities:

• 1. Prepare, review and or approve validation documentation or manage the process (fulfilling the Quality Assurance role) in accordance with the relevant processes (e.g. Quality Management System). Ensure systems are validated and fit for purpose, that significant risks are identified and mitigated, and that the approach and rigor of validation is in proportion to the risks the systems present to regulated business processes
• 2. Providing Domain Expertise and consultancy in GxP and Records Management areas, partnering with Business Quality functions for end to end compliance, supporting internal or external GxP or other relevant inspections partnering with Tech and the business.
• 3. Manage the deployment, maintenance and inspection support of multiple enterprise systems including responsibility for the developing solutions that maintain compliance and keep validation on schedule and on budget
• 4. Ensure issues/risks are identified, mitigated and/or escalated for items that could adversely impact quality compliance associated with projects/systems and as the SME/Specialist support the audit of third party suppliers of GxP software and services
• 5. Support problem identification/resolution/avoidance; typically involving ongoing interaction with management teams within Tech functions, site and local operating company Quality organizations, and Third Party suppliers/service providers.

Business Expertise:

• Ability to demonstrate proficiency and knowledge of computerized systems requirements defined by applicable European, US, or other relevant legislations, Health authorities and/or industry groups
• Knowledge of validation and qualification processes for Technology, particularly within a cloud environment
• Demonstrated experience in audit and assurance, external inspections and regulatory audits.
• Demonstrated experience in control framework design and implementation, i.e Tech control framework, three lines of defence model
• Technical knowledge of IT Software Development Lifecycle, Agile delivery methodolgy and industry best practices
• Good communicator, able to present ideas coherently leading to achieving a consensus, even where stakeholders are from a diverse range of business areas.

Diverse problem solving across Technology and Regulatory landscape. Risk-based decisions must be made based on the combination of global regulatory requirements and Haleon technology capability. Regulations can be open to interpretation and require current and ongoing experience with regulatory agencies.Ineffective management of computer system validation processes could lead to business disruption through poor performing technology. Ineffective management of the QCA organisation could lead to poor validation/qualification practices which could lead to regulatory fines, warning letters, removal of products for sale from markets.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.As you apply, we will ask you to share some personal information, which is entirely voluntary. 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. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.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 Haleons compliance to all federal and state US Transparency requirements.

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