Asset Quality Lead

Responsibilities

• Lead the development and implementation of quality assurance strategies and processes to support clinical trial activities
• Conduct comprehensive quality assessments and audits to ensure compliance with regulatory standards and guidelines
• Collaborate with cross-functional teams to identify and address quality issues and implement corrective actions as needed
• Provide expert guidance and support to staff regarding quality assurance policies, procedures, and best practices
• Contribute to the continuous improvement of quality management systems and documentation

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred
• Minimum of 10 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with significant experience in a leadership role
• Extensive knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations)
• Strong analytical and problem-solving skills, with the ability to identify and resolve complex quality issues
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders
• Willingness to travel as required (approximately 25%)

Pay

$100,000 – $130,000 annually

Schedule

Remote - US based candidates only, no visa sponsorship available