Audit-Driven Clinical Quality & Compliance Specialist

Meeveem Limited; Reading; On-site; GBP 40,000 - 60,000; Full time

Benefits offered by this job

Competitive base salary

Health and wellbeing programmes

Retirement and pension plans

Learning and development opportunities

Job summary

ICON is seeking a Clinical Quality Compliance Specialist to design and analyse clinical trials, interpreting complex medical data, and contribute to advancing innovative treatments and therapies.

You will contribute to quality assurance and compliance activities, collaborating across teams and supporting audits, with a travel requirement of around 65%. The role requires a scientific degree and experience in regulatory standards such as FDA/EMA, ICH-GCP, and ISO.

Qualifications

• Bachelor's degree in a scientific/healthcare-related field.
• Experience in clinical quality assurance or compliance within pharma/biotech/CRO.
• Knowledge of FDA/EMA regulations, ICH-GCP guidelines, and ISO standards.
• Strong attention to detail and analytical skills.
• Excellent communication, organizational and problem-solving abilities with good teamwork.
• Willingness to travel approximately 65%.

Responsibilities

• Develop and implement quality management systems to ensure regulatory compliance.
• Participate in internal and external audits and inspections, supporting preparation, documentation and response activities.
• Conduct quality reviews of clinical trial documentation, protocols and study reports to ensure adherence to quality standards.
• Collaborate with cross-functional teams to address quality issues, implement CAPAs, and drive continuous improvement.
• Provide guidance on quality compliance and promote awareness of quality standards and best practices.

Skills

Quality assurance

Compliance

Attention to detail

Analytical skills

Communication

Teamwork

Problem-solving

Willingness to travel

Education

Bachelor's degree in science

Job description

ICON is seeking a Clinical Quality Compliance Specialist to design and analyse clinical trials, interpreting complex medical data, and contribute to advancing innovative treatments and therapies.

You will contribute to quality assurance and compliance activities, collaborating across teams and supporting audits, with a travel requirement of around 65%. The role requires a scientific degree and experience in regulatory standards such as FDA/EMA, ICH-GCP, and ISO.