Senior Director, Quality & Compliance at Jobgether – United States

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Director, Quality & Compliance in United States.

This leadership role provides strategic oversight and operational direction for clinical quality and compliance programs across all phases of clinical research. The Senior Director, Quality & Compliance will ensure studies adhere to global regulations, sponsor requirements, and internal quality standards while fostering a culture of quality and data integrity. This role leads GCP-focused quality systems, audit programs, issue management, and inspection readiness activities. You will collaborate with cross-functional teams to proactively identify and mitigate risks, provide expert guidance, and support regulatory inspections. The position offers a dynamic environment where continuous improvement, operational excellence, and professional development of QA staff are prioritized. The role also involves advising senior management and clients on compliance strategies and quality initiatives to support organizational growth.

• Lead and maintain GCP quality assurance programs, ensuring compliance with FDA, EMA, ICH regulations, and internal procedures
• Oversee risk-based audit programs including clinical sites, vendors, internal processes, and trial master files (TMF)
• Manage quality events, deviations, and corrective action/preventive action (CAPA) processes
• Provide regulatory guidance, training, and support to cross-functional teams to promote compliance and a culture of quality
• Ensure inspection readiness and support health authority and sponsor audits globally
• Develop and mentor Quality & Compliance staff, providing leadership and fostering continuous improvement
• Review clinical and nonclinical documentation to maintain data integrity and adherence to regulatory standards
• Contribute to quality initiatives, process optimization, and corporate compliance programs while collaborating with Operations and other stakeholders

Requirements:

• 10+ years of experience in GCP Quality Assurance within CRO, pharmaceutical, or biotechnology environments
• Bachelor’s degree in life sciences or related field (advanced degree preferred)
• Demonstrated experience leading and conducting GCP audits across sites, vendors, internal processes, and TMF
• Strong knowledge of FDA, EMA, and ICH regulations and global GCP guidelines
• Experience supporting regulatory inspections and inspection readiness activities
• Proven leadership and supervisory experience managing quality personnel
• Strong analytical, problem-solving, and communication skills with the ability to work cross-functionally
• Ability to interpret regulatory requirements and translate them into effective quality systems and risk-based approaches
• Availability to travel up to 25% domestically and/or internationally
• Preferred: CRO, pharmaceutical, or medical device experience, advanced degree, experience hosting client/health authority inspections

Benefits:

• Competitive base salary with discretionary annual bonus
• Comprehensive healthcare coverage including medical, dental, and vision
• Retirement savings plan with company match
• Paid time off, parental leave, and sick leave
• Life and disability insurance
• Professional development and training opportunities
• Flexible work arrangements including remote options