Associate Director, Quality Assurance - CMC

Seaport Therapeutics is a clinical-stage biopharmaceutical 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 Glyph™ technology platform. All therapeutic candidates in its pipeline are based on the Glyph platform, 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 is guided by an extensive network of renowned scientists, clinicians, and key opinion leaders.

About the role

Reporting to the Head of Quality, this role manages GMP quality assurance activities supporting clinical development programs, ensuring compliance with Good Manufacturing Practice (GMP), regulatory requirements, and company policies. The position is instrumental in supporting clinical trials, advancing the development of innovative products, and maintaining a culture of quality across the organization. This position is based in Boston’s Seaport area, with a strong preference for being onsite 4 days per week.

Responsibilities

• Manages QA resources assigned to supporting cGMP programs, including the review and approval of project-specific batch records, procedures, protocols, and reports
• Acts as the primary liaison with CMC and CMOs to approve master documents and executed records in support of GMP manufacturing for API, drug product, and packaged materials
• Manages the oversight, review, and approval of deviations and investigations pertaining to cGMP production and testing
• Coordinates product release activities at CMOs, including acting as QA approver as necessary
• Liaises with Clinical Supply Chain to ensure on-time release of products
• Assists with CMC-related regulatory submissions as required
• Interacts and communicates with CMC and CMO to assure expectations are established, agreed to, and achieved
• Supports the establishment, preparation, and communication of GMP quality metrics; identifies and works with functional areas to facilitate improvements
• Supports the preparation of Product Quality Reviews; tracks and trends the performance of validated programs in support of continuous process verification
• Other duties as assigned
• 10-20% travel to support CMO activities

Requirements

• Bachelor's degree in Science or related field
• 8–10 years of experience in the pharmaceutical or biotechnology industry, with significant expertise in Quality or a related function
• Strong knowledge of GMP and regulatory requirements, with hands-on experience managing external CMOs
• Strong organizational, analytical, and problem-solving skills, with the ability to manage multiple priorities in a dynamic environment
• Small molecule drug development experience highly desirable
• Motivated by patient focus and personal commitment to high performance and results
• Possesses high integrity and exceptional work ethic

Benefits

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.

Pay

The expected salary range for this role is $180,000–$195,000, with the final offer based on experience, market data, and internal equity.