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Haleon logo

GxP (GCP, GLP, GVP) Quality Assurance Associate Director

Haleon
Posted 5 hours ago
🇮🇳India🏢Hybrid📁Engineering & Development
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Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve grown, evolved and are now entering an exciting new chapter – one filled with bold ambitions and enormous opportunity. Our trusted portfolio of brands – including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® – lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science. Now it’s time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture. About the Role This role provides independent Quality Assurance oversight, auditing, inspection support, and strategic compliance advice across Haleon GxP activities, with an integrated scope covering GVP, GCP, GLP and related GCLP activities. The role supports the protection of patients, consumers, and research participants, reinforces data integrity and regulatory compliance, and helps drive continuous improvement across Consumer Safety, Clinical Development, and broader R&D processes. Plan, lead, and conduct GVP, GCP, GLP/GCLP audits independently or as part of a broader audit team. Support functional activities across pharmacovigilance, clinical and non-clinical development to ensure compliance with applicable regulatory requirements, guidelines, laws, and Haleon quality standards. Act as a trusted GxP quality partner with internal and external stakeholders to resolve compliance issues, monitor trends, strengthen quality culture, and drive sustainable improvements. Key Responsibilities Plan, lead, and conduct global risk-based GVP, GCP, GLP and GCLP audits, including process audits, Local Operating Companies, clinical investigator sites, laboratories, Licensing Partners, External Service Providers, and internal R&D processes. Communicate and document audit findings clearly, support audit report finalization, compile CAPA evidence, and track CAPAs through to effective and timely completion. Maintain and contribute to the global GxP audit programme, including audit planning, risk-based prioritization, schedule development, and alignment with business priorities. Contribute to and support regulatory inspection readiness. Provide independent GxP quality advice to Consumer Safety, Clinical Development, Regulatory, Medical, Quality, Commercial and other relevant R&D stakeholders. Support the development, implementation, and maintenance of GxP Quality Management Systems, SOPs, templates, quality agreements and clinical quality schedules in line with applicable regulations and Haleon requirements. Monitor, screen and interpret relevant global, regional and national GVP, GCP and GLP regulatory requirements and guidelines, and translate expectations into practical quality advice. Provide subject matter expert input into compliance strategy, quality improvement initiatives, process optimization, programme governance, and risk assessments. Generate, review and use quality metrics, KPIs, audit trends, inspection insights and other compliance information to identify risks, drive improvements and support management oversight. Train, coach, guide and influence business functions and GxP stakeholders on quality expectations, regulatory standards, audit readiness and best practices, while mentoring colleagues and strengthening collaboration within the team. Qualifications and Skills Minimum level of education: Bachelor of Science degree, or equivalent qualification / relevant professional experience. Preferred level of education: Master of Science degree, PhD, Pharmacy degree, Public Health, Healthcare Provider qualification, or equivalent background in Chemistry, Biology, Life Sciences or related discipline. Job-related experience: 10+ years of pharmaceutical, consumer healthcare, R&D, Quality or related industry experience, including significant experience (minimum 3 years) in Quality Assurance and auditing across at least one major GxP area. Preferred audit experience: demonstrated experience leading or supporting GVP, GCP and/or GLP audits, with the ability to operate across multiple GxP domains and develop broader cross-GxP expertise. Inspection readiness experience: experience supporting competent authority inspections, License Partner audits, or significant quality investigations is preferred. Strong knowledge of applicable GVP, GCP, GLP and related regulatory requirements, guidelines, industry expectations, and company policies and procedures. Broad scientific, pharmaceutical, consumer healthcare or R&D background with relevant understanding of pharmacovigilance, clinical development, non-clinical research and associated quality systems. Ability to influence, negotiate and build credibility with internal and external stakeholders, including senior leaders, technical experts, audit auditees, vendors and partners. Strong judgement, independence and organizational awareness, with the ability to identify, escalate and support resolution of significant or complex compliance issues. Ability to work independently, make risk-based decisions with appropriate supervision, and collaborate effectively across a geographically dispersed matrix organization. Demonstrated project management skills, including planning, prioritization, stakeholder coordination and delivery of complex cross-functional activities. Ability to deliver or support process improvement initiatives, use metrics and trends to inform quality decisions, and contribute to a proactive quality culture. Self-motivated, adaptable and quick to learn, with a willingness to share knowledge, receive feedback and contribute to team capability building. Strong verbal, written and presentation skills, including the ability to produce clear audit documentation and communicate complex compliance matters effectively. Ability and willingness to travel domestically and internationally, and to work effectively in a hybrid or remote environment across time zones. Job Posting End Date 2026-08-31 Equal Opportunities Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. It’s important to us that Haleon is a place where all our employees feel they truly belong. During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees. The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions. Adjustment or Accommodations Request If you require a reasonable adjustment or accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific adjustments you are requesting. We’ll provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence. Note to candidates The Haleon recruitment team will contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.

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