Director, Clinical Quality Assurance

The role

The Director, Clinical Quality Assurance leads GCP compliance and quality oversight for clinical programs. This person manages audits, inspection readiness, and vendor oversight to ensure global regulatory compliance.

What you will do

• Inform and contribute to audit planning and strategy
• Perform and/or coordinate clinical site and vendor audits
• Oversee deviations, quality issues, CAPAs, effectiveness checks, root cause analyses, and associated KPIs
• Advise internal stakeholders and external partners on GCP compliance matters
• Support inspection readiness activities and co-host regulatory inspections
• Develop and deliver GCP-related training
• Contribute to the creation, revision, and maintenance of policies, SOPs, and work instructions
• Conduct and/or manage the qualification and oversight of service providers
• Assess and escalate compliance risks identified through audits
• Support investigational new drug (IND) applications and related correspondence

Required qualifications

• Bachelor’s degree with 12+ years of related experience
• Deep knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GVP, GxP)
• Broad clinical development experience across all phases (Phase I through BLA/NDA)
• Strong understanding of GCP quality principles spanning preclinical, clinical, and commercial stages
• Proven experience developing and implementing risk-based clinical quality assurance programs
• Demonstrated success leading clinical site and supplier audits, managing regulatory inspections, and responding to findings
• Skilled at effectively communicating quality events and outcomes to internal stakeholders
• Excellent interpersonal, verbal, and written communication skills
• Results-oriented, with the ability to set clear objectives, manage competing priorities, and meet dynamic timelines
• Flexible and creative problem solver with a proactive mindset
• Highly collaborative team player
• Willingness to travel up to 20% based on business needs

Nice to have

• preferably in life sciences with 8+ years of experience in a Clinical Quality Assurance role, or an equivalent combination of PV and QA experience
• Working knowledge of multiple therapeutic areas is a plus

About the company

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines. The company uses its proprietary GlyphTM technology platform to advance clinically validated mechanisms.