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 the United States.

This senior leadership role provides strategic and operational oversight for clinical quality assurance and regulatory compliance across global clinical development programs. You will lead the design, implementation, and continuous improvement of quality systems, risk-based audits, and inspection readiness initiatives, ensuring adherence to GCP, FDA, EMA, and ICH regulations. Acting as a trusted advisor, you will partner cross-functionally to identify and mitigate quality risks, mentor and develop QA teams, and support internal and external stakeholders in achieving compliance excellence. This position requires a combination of regulatory expertise, operational leadership, and strategic vision to influence quality culture, enhance data integrity, and support clinical success on a global scale.

• Lead enterprise-wide GCP quality assurance programs across clinical sites, internal processes, TMF audits, and vendor qualification audits
• Direct the development, implementation, and continuous improvement of the Quality Management System (QMS), including SOPs, training, CAPAs, and risk-based audit programs
• Ensure inspection readiness and support regulatory inspections with health authorities and sponsors globally
• Provide guidance on regulatory compliance throughout the clinical development life cycle and review documentation to ensure adherence to GCP and global regulatory standards
• Mentor and develop Quality & Compliance staff, fostering a culture of quality, integrity, and continuous improvement
• Collaborate cross-functionally with operational teams to proactively identify and mitigate compliance risks
• Support business development initiatives, including proposal development, RFP responses, and client interactions

• Bachelor’s degree in life sciences or related field; advanced degree preferred
• 10+ years of GCP Quality Assurance experience within CROs, biotechnology, or pharmaceutical organizations
• Proven experience conducting and leading audits across clinical sites, internal processes, TMF, and vendors
• Strong knowledge of FDA, EMA, and ICH regulations, with experience supporting regulatory inspections and inspection readiness activities
• Demonstrated leadership, cross-functional collaboration, and strategic problem-solving skills
• Ability to interpret regulatory requirements and implement effective quality systems, risk-based approaches, and compliance guidance
• Availability for up to 25% domestic and international travel
• Preferred: Graduate or postgraduate degree in scientific or healthcare discipline, CRO/Pharmaceutical/Medical Device experience, experience hosting client or health authority inspections

• Competitive base salary with discretionary annual bonus
• Comprehensive health insurance including medical, dental, and vision coverage
• Retirement savings plan with company matching contributions
• Paid time off, sick leave, and parental leave
• Life insurance and disability coverage
• Career development support, including training and continuing education
• Flexible work environment and remote work options