Clinical Quality Compliance Lead

📋 Description

• Supervise quality assurance and compliance initiatives, ensuring that deliverables align with quality standards and timelines.

• Design and implement thorough quality management systems and procedures to guarantee adherence to regulatory standards, industry norms, and organizational policies.

• Direct internal and external audits and inspections, encompassing planning, execution, and follow-up actions to resolve findings promptly.

• Perform regular quality assessments of clinical trial documentation, protocols, and study reports, pinpointing areas for enhancement and enacting corrective measures as needed.

• Offer leadership and support to the clinical quality compliance team, which includes training, mentoring, and managing performance.

• Work collaboratively with cross-functional teams to evaluate quality risks, create risk mitigation plans, and promote continuous improvement initiatives.

⛳️ Requirements

• A Bachelor's degree or higher in a pertinent scientific discipline or healthcare-related field.

• Prior experience in clinical quality assurance or compliance within the pharmaceutical, biotechnology, or CRO sectors.

• In-depth knowledge of regulatory requirements, including FDA/EMA regulations, ICH-GCP guidelines, and ISO standards.

• Strong leadership and project management capabilities, with the capacity to effectively prioritize tasks and manage resources to achieve goals.

• Exceptional communication, interpersonal, and problem-solving abilities, with the skill to influence and collaborate with stakeholders at all organizational levels.

• Willingness to travel to sites as necessary, approximately once a month.

🏝️ Benefits

• Various annual leave entitlements.

• A range of health insurance options to accommodate you and your family’s needs.

• Competitive retirement planning options to optimize savings and plan confidently for the future.

• Global Employee Assistance Programme, TELUS Health, providing 24-hour access to a worldwide network of over 80,000 independent specialized professionals dedicated to supporting you and your family’s well-being.

• Life assurance.

• Flexible country-specific optional benefits, such as childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, and more.