Position Purpose
This role is responsible for providing overall quality and compliance during the clinical development processes (GCP and GLP) across all categories. The incumbent will plan and conduct audits, support pre‑clinical and clinical activities to ensure adherence to regulatory requirements, and serve as a partner with stakeholders to resolve compliance issues, drive quality improvements, and protect patient safety and data integrity.
Accountabilities & Responsibilities
* Plan and conduct global GCP/GLP/GCLP audits independently, as a Lead, or as a team member.
* Communicate and document audit findings, compiling corrective and preventive action (CAPA) evidence.
* Maintain or contribute to the audit program, covering clinical investigator sites, external service providers, and internal processes.
* Support the development and maintenance of the Clinical Quality Schedule in Master Services Agreements.
* Coordinate and assist internal stakeholders during regulatory inspections (e.g., FDA, EMA, MHRA).
* Assist in developing and implementing a Quality Management System and SOPs for clinical/non‑clinical activities in compliance with GCP/GLP regulations; participate in the 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 on 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 business functions on GCP/GLP procedures, compliance, and regulatory standards to enhance the quality culture.
* Build and maintain beneficial working relationships with internal and external stakeholders.
Qualifications
* Minimum Level of Education: Bachelor of Science (BS) Degree.
* Preferred Level of Education: Master of Science Degree or PhD in Biology, Biochemistry, or equivalent.
* Job‑Related Experience: 10+ years in the pharmaceutical industry with at least 5–7 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 GCP and GLP regulatory requirements, guidelines, and company policies & procedures.
* Detailed knowledge of human subject research activities, clinical development processes, and R&D systems.
* Self‑motivated, quick learner who proactively shares knowledge and welcomes feedback from team members.
* Ability to deliver key process improvement initiatives.
* Adaptability to changing business and risk environments.
* Capability to work independently and as part of a team.
* High degree of organizational awareness and resolution orientation for compliance issues.
* Strong verbal, written, and presentation skills.
* Willingness to travel domestically and internationally.
* Ability to interact and work remotely, either part‑time or full‑time.
Equal Opportunities
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. During the application process, personal information may be requested voluntarily to support inclusion and belonging programmes. This information will be kept confidential, used only for legitimate business purposes, and never employed in making employment decisions.
Adjustment or Accommodations Request
If you require a reasonable adjustment or accommodation at any stage of the application process, please inform the recruiter by describing the specific adjustments requested. Haleon will provide all reasonable adjustments to support you throughout recruitment and treat the information in confidence.
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