At a Glance
- Tasks: Ensure quality and compliance in clinical development processes through audits and stakeholder collaboration.
- Company: Leading pharmaceutical company focused on innovative research and development.
- Benefits: Attractive salary, comprehensive health benefits, and opportunities for professional growth.
- Other info: Dynamic role with opportunities to mentor and influence the next generation of quality professionals.
- Why this job: Make a real difference in patient safety and data integrity while working with industry experts.
- Qualifications: Bachelor's degree required; advanced degrees preferred, plus extensive experience in clinical quality assurance.
The predicted salary is between 70000 - 90000 £ per year.
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.
Clinical Development Quality Assurance, Associate Director in Surrey employer: Haleon Plc.
As a leader in the pharmaceutical industry, our company offers an exceptional work environment for the Clinical Development Quality Assurance, Associate Director role. We prioritise employee growth through continuous training and mentorship, fostering a culture of quality and compliance that empowers our team to make impactful contributions. Located in a vibrant area, we provide competitive benefits and a collaborative atmosphere that values innovation and integrity, making us an ideal employer for those seeking meaningful and rewarding careers.
