Associate Director, Quality Assurance - CMC

Seaport Therapeutics is seeking an experienced Associate Director, QA 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. This position requires a presence in the Seaport area of Boston, with a strong preference for being onsite 3 – 4 days per week to foster collaboration and effective leadership as the Quality function is established. The role will report to the VP, Head of Quality.

Seaport Therapeutics 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 liver metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that was involved in inventing and advancing KarXT and other neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders across neurological specialties. For more information, please visit www.seaporttx.com

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 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