Seaport Therapeutics is seeking an experienced
Director, Clinical Quality Assurance to manage clinical quality activities supporting clinical development programs, ensuring compliance with regulatory requirements and company policies. This role reports to the VP of Quality.
The Director, Clinical Quality Assurance leads GCP compliance and quality oversight for clinical programs. This role is responsible for developing and implementing risk-based strategies; managing audits, inspection readiness, and vendor oversight; and ensuring global regulatory compliance. This role partners cross-functionally to drive continuous improvement, inspection readiness, and sponsor oversight, while proactively identifying and mitigating quality risks. As a subject matter expert, this role establishes program support to uphold industry best practices and regulatory requirements.
The ideal candidate will embrace a collaborative, innovative culture that embodies our values of service to patients impacted by mental health conditions, with a "we own it" mentality, demonstrating entrepreneurial spirit and technical excellence while fostering teamwork and continuous improvement. This position is based in Boston's Seaport area, with a strong preference for being onsite 4 days per week.
Summary of Key Responsibilities- Inform and contribute to audit planning and strategy
- Perform and/or coordinate clinical site and vendor audits
- Oversee deviations, quality issues (QIs), CAPAs, effectiveness checks, root cause analyses, and associated KPIs
- Advise internal stakeholders and external partners on GCP compliance matters and identify emerging non-compliance trends
- 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 in alignment with global regulatory requirements
- Conduct and/or manage the qualification and oversight of service providers
- Ensure service providers adhere to quality programs and applicable regulations, maintaining inspection readiness
- Assess and escalate compliance risks identified through audits to protect subject safety, data integrity, and business continuity
- Lead or support the preparation for and response to regulatory audits and inspections, ensuring adherence to requirements and timely resolution of findings
- Support investigational new drug (IND) applications and related correspondence with global regulatory authorities
- Other duties as assigned
Qualifications- Bachelor's degree with 12+ years of related experience preferably in life sciences with 8+ years of experience in a Clinical Quality Assurance role, or an equivalent combination of PV and QA experience
- Deep knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GVP, GxP), including safety reporting requirements
- 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 (must have)
- Working knowledge of multiple therapeutic areas is a plus
- 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 who fosters open communication and cross-functional cooperation
- Willingness to travel up to 20% based on business needs
At Seaport, we believe transparency and fairness are key to building a culture of trust, respect, and collaboration. We care deeply about the happiness of our team and strive to ensure our total rewards (monetary and non-monetary) program reflects the value each person brings. The expected salary range for this role is
$198,000-$225,000, with the final offer based on experience, market data, and internal equity. We encourage open conversations with our talent acquisition team about compensation early in the process to ensure alignment from the start.
