Reporting to the Head of Quality, Seaport Therapeutics is seeking an experienced
Associate Director, Quality Assurance CMC to manage GMP quality assurance activities supporting clinical development programs, ensuring compliance with Good Manufacturing Practice (GMP), regulatory requirements, and company policies. This role is instrumental in supporting clinical trials, advancing the development of innovative products, and maintaining a culture of quality across the organization.
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- Manages QA resources assigned to supporting cGMP programs, including the review and approval of project-specific batch records, procedures, protocols, and reports
- Act 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
- Coordinate product release activities at CMOs including acting as QA approver as necessary
- Liaise with Clinical Supply Chain to ensure on-time release of products
- Assist 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 as appropriate 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
Qualifications- Bachelor's degree in Science or related fields
- 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
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 $180,000-$195,000 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.
