Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary GlyphTM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects.

Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. com .

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.

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.

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

and timely resolution of findings Support investigational new drug (IND) applications and related correspondence with global regulatory authorities Other duties as assigned

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

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

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