Clinical Development Quality Assurance, Associate Director

Requirements

• Minimum Level of Education : Bachelor of Science (BS) Degree
• Preferred Level of Education : Master of Science Degree or PhD Biology, Biochemistry, or equivalent
• Job-Related Experience : 10+ years of pharmaceutical industry experience with at least 5 to 7 years in clinical quality assurance and auditing.
• COMPETENCIES AND SKILLS :
• Proven ability to influence and negotiate with internal and external stakeholders .
• Expert knowledge of applicable Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulatory requirements and guidelines, and company policies & procedures .
• Detailed knowledge of human subject research activities, clinical development processes and R&D systems .
• Self-motivated and quick learner who proactively shares knowledge and welcomes knowledge and feedback from other team members .
• Ability to deliver key process improvement initiatives .
• Ability to adapt to changing business and risk environment .
• Ability to work independently and as part of a team .
• High degree of organizational awareness and working towards resolution with compliance issues .
• Demonstrated ability for good verbal, written and presentation skills .
• Ability and desire for domestic and international travel .
• Ability to interact and work remotely either part or full time .
• Job Posting End Date
• 2026-07-15
• Equal Opportunities
• During the application process, we may ask you to share s

Benefits

Additional Information

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. POSITION PURPOSE This role is responsible for providing overall quality and compliance during the clinical development processes (GCP and GLP), across all categories: Plan and conduct GCP /GLP/GCLP audit s independently or as a Lead or as a team member or in a support role . Support functional activities related to pre-clinical and clinical development to ensure these activities are conducted in accordance with applicable regulatory requirements, guidelines, laws, and established quality standards and practices . Serve as a GCP and GLP partner with stakeholders to solve compliance issues, drive quality improvements and improve animal, human research practices, patient safety, and data integrity. ACCOUNTABILITIES/RESPONSIBILITIES Plan and conduct global GCP/GLP/GCLP audits independently / as a Lead / as a team member / in a supportive role . Communicate and document audit findings, compile corrective and preventive action (CAPA) evidence . Maintain audit program and/or contribute to elaborate audit program . The scope of the audit program includes clinical investigator sites, external service providers, and internal processes. Support the development and maintenance of Clinical Quality Schedule in Master Services Agreements Coordinate and support internal stakeholders during regulatory inspections ( e.g ., FDA, EMA, MHRA) . Assist in the development and implementation of a Quality Management System and SOPs for clinical/non-clinical activities in compliance with applicable GCP and GLP regulations; participate in maintenance of CDA&I SOPs . Escalate and investigate significant compliance issues to line management Mentor and support other members of CDA&I Provide expert advice for GCP/GLP compliance strategy, quality improvement, process and program initiatives and risk assessments . Support Significant Quality Investigations (SQIs) and Serious Breaches (SBs) for human subject research activities, where required Train/coach, guide, and influence the respective business functions on GCP/GLP procedures, compliance, and regulatory standards, enhance quality culture . Build and maintain beneficial working relationships with internal and external stakeholders .

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at gsknch? Share your experience