CMC Quality Assurance Director – Onsite 4 Days/Week

Seaport Therapeutics; Boston (MA); On-site; USD 180,000 - 195,000; Full time

Job summary

Seaport Therapeutics is seeking an experienced Associate Director, Quality Assurance CMC to lead QA activities supporting clinical programs and ensuring GMP compliance. Based in Boston's Seaport area, the role emphasizes collaboration, integrity, and a strong bias for action, with onsite work four days a week.

The candidate will manage QA resources, interface with CMOs/CMC, and support regulatory submissions while driving quality metrics and continuous improvement across programs.

Qualifications

• Bachelor's degree in Science or related field.
• 8–10 years of experience in pharmaceutical/biotech industry with focus on Quality or related function.
• Strong knowledge of GMP and regulatory requirements; hands-on CMOs management.
• Experience coordinating with CMOs and ensuring GMP compliance across programs.
• Small molecule drug development experience is desirable.

Responsibilities

• Manage QA resources supporting cGMP programs; review/approve batch records, procedures, protocols and reports.
• Serve as primary liaison with CMC and CMOs to approve master documents and executed records.
• Oversee deviations and investigations related to cGMP production/testing.
• Coordinate product release activities at CMOs; QA approver as needed.
• Interface with Clinical Supply Chain to ensure on-time release of products.
• Assist with CMC-related regulatory submissions as required.
• Communicate with CMC/CMO to align expectations and deliverables.
• Develop GMP quality metrics and drive cross-functional process improvements.
• Contribute to Product Quality Reviews and continuous process verification.

Skills

GMP knowledge

CMO management

Regulatory knowledge

Analytical skills

Organizational skills

Problem-solving

Education

Bachelor's degree in Science

Job description

Seaport Therapeutics is seeking an experienced Associate Director, Quality Assurance CMC to lead QA activities supporting clinical programs and ensuring GMP compliance. Based in Boston's Seaport area, the role emphasizes collaboration, integrity, and a strong bias for action, with onsite work four days a week.

The candidate will manage QA resources, interface with CMOs/CMC, and support regulatory submissions while driving quality metrics and continuous improvement across programs.