Seaport Therapeutics

Director, Clinical Quality Assurance

Boston, MA · Director

Sponsorship not specified$198k-$225kDetected 35 days ago

GCPRecruitingFDA RegulatoryAnimal StudiesCommunicationGxP

About the role

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs.
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.
For more information, please visit www.seaporttx.com.

Perform and/or coordinate clinical site and vendor audits
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
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

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
Excellent interpersonal, verbal, and written communication skills (must have)
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
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

The expected salary range for this role is $198,000–$225,000, with the final offer based on experience, market data, and internal equity.

This role partners cross-functionally to drive continuous improvement, inspection readiness, and sponsor oversight, while proactively identifying and mitigating quality risks

This listing is sourced directly from Seaport Therapeutics's careers page and normalized into a canonical job model.