Clinical Quality Compliance Lead

This is a fully remote position, open to applicants in United States.

📋 Description

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

• Create and apply comprehensive quality management systems and processes.

• Lead both internal and external audits and inspections, overseeing planning, execution, and follow-up tasks.

• Resolve audit and inspection findings promptly and effectively.

• Perform regular quality assessments of clinical trial documentation, protocols, and study reports.

• Identify opportunities for improvement and implement corrective measures.

• Provide leadership and support to the clinical quality compliance team, including training, mentoring, and performance evaluations.

• Collaborate with cross-functional teams to evaluate quality risks and formulate risk mitigation strategies.

• Propel continuous improvement efforts.

⛳️ Requirements

• Bachelor's degree or higher in a relevant 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 standards, including FDA/EMA regulations, ICH-GCP guidelines, and ISO standards.

• Strong leadership and project management capabilities.

• Ability to prioritize tasks effectively and manage resources to achieve goals.

• Excellent communication, interpersonal, and problem-solving abilities.

• Capacity to influence and collaborate with stakeholders at all organizational levels.

• Willingness to travel as needed, approximately 65% of the time.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Learning and development opportunities through structured training and career pathways.