Clinical Development Quality Assurance, Associate Director

Position Purpose

• Provide overall quality and compliance during clinical development processes (GCP, GLP, GCLP).
• Plan and conduct GCP/GLP/GCLP audits independently or as a lead or team member.
• Support functional activities related to pre‑clinical and clinical development to ensure regulatory compliance and quality standards.
• Serve as a GCP and GLP partner with stakeholders to solve compliance issues, drive quality improvements, and enhance animal, human research practices, patient safety, and data integrity.

Accountabilities / Responsibilities

• Plan and conduct global GCP/GLP/GCLP audits independently, as a lead, team member, or in a supportive role.
• Communicate and document audit findings, compile corrective and preventive action (CAPA) evidence.
• Maintain and contribute to an audit program covering clinical investigator sites, external service providers, and internal processes.
• Support the development and maintenance of a 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, and participate in maintenance of CDAI SOPs.
• Escalate and investigate significant compliance issues to line management.
• Mentor and support other members of CDAI.
• 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 business functions on GCP/GLP procedures, compliance, and regulatory standards to enhance a quality culture.
• Build and maintain beneficial working relationships with internal and external stakeholders.

Qualifications

• Minimum education: Bachelor of Science (BS) degree.
• Preferred 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 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 and quick learner who proactively shares knowledge and welcomes feedback.
• Ability to deliver key process improvement initiatives.
• Ability to adapt to a changing business and risk environment.
• Ability to work independently and as part of a team.
• High degree of organizational awareness and focus on resolving compliance issues.
• Demonstrated good verbal, written, and presentation skills.
• Willingness to travel domestically and internationally.
• Ability to 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. We create an inclusive culture where different backgrounds and views are valued and respected, supporting the needs of our consumers and the full potential of our people.

#J-18808-Ljbffr…