Role Purpose
To support the execution of GxP audit and inspection activities across GCP, GLP, and GVP, ensuring compliance with applicable global regulations and internal quality standards, while contributing to inspection readiness and continuous quality improvement initiatives.
Responsibilities
- Support and conduct GCP, GLP, and GVP audits as a lead auditor or team member, covering internal processes, investigator sites, vendors, and service providers.
- Contribute to and coordinate regulatory inspection support activities (e.g., FDA, EMA, MHRA, Health Canada), including preparation, coordination, and follow‑up actions.
- Support the risk‑based audit programme, including audit preparation, execution, reporting, and CAPA follow‑up and tracking.
- Document audit observations, assess responses, and review CAPA evidence for adequacy and timely closure.
- Provide quality and compliance support to ensure clinical, non‑clinical, and pharmacovigilance activities are conducted in accordance with GCP, GLP, and GVP requirements.
- Support the development, maintenance, and periodic review of GxP SOPs, written standards, and QMS documentation.
- Act as a quality partner to assigned stakeholders by advising on compliance questions, issue resolution, and quality improvement actions.
- Assist with quality metrics, trend analysis, and reporting to support identification of compliance risks and areas for improvement.
- Support investigations of compliance issues, serious breaches, or quality events, escalating issues as appropriate.
- Deliver training and coaching to business functions to promote GxP awareness and a strong quality culture.
Qualifications
- 6+ years of pharmaceutical industry experience in R&D and Quality/Compliance roles.
- Bachelor of Science Degree (minimum level of education) with specialization in Chemistry, Pharmacy, Biology, Life Science, Public Health or Healthcare Provider.
- Master of Science Degree or PhD in Biology, Biochemistry, or equivalent is preferred but not mandatory.
Competencies & Skills
- Working knowledge of GCP, GLP, and GVP regulations and guidelines.
- Ability to support and perform audits using a risk‑based approach.
- Good stakeholder management and communication skills.
- Ability to work independently on assigned tasks with appropriate supervision.
- Strong written, verbal, and documentation skills.
- Organized, detail‑oriented, and able to manage multiple priorities.
- Willingness to travel domestically and internationally as required.
Equal Opportunity Statement
Haleon is 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. We are an equal‑opportunity employer.
