Director, Clinical Quality Assurance

Seaport Therapeutics is seeking an experienced Director, Quality Assurance - R&D to manage GCP, GLP, and GVP quality activities supporting preclinical and clinical development programs, ensuring compliance with regulatory requirements and company policies.

This position will manage the development of risk assessments, audit programs, and planning and resourcing audits. It will also lead or partner with colleagues to prepare for GCP/GLP/PV regulatory inspections. Responsibilities include providing regulatory compliance and QA guidance to preclinical, clinical, and drug safety teams, reviewing and contributing QA input into policies and procedures, and leading training on SOPs and regulatory topics based on needs analysis.

The role requires a presence in the Seaport area of Boston, with a preference for being onsite 3–4 days per week to foster collaboration. The position reports to the VP, Head of Quality.

Key Responsibilities include:

1. Developing, implementing, and maintaining QA GCP/GLP/PV systems, risk management processes, and SOPs
2. Providing updates and strategic recommendations to leadership on GCP, GLP, and GVP quality oversight
3. Ensuring compliance of clinical activities to relevant quality and regulatory standards
4. Presenting quality metrics and recommending continuous improvements
5. Managing risk-based identification and resolution of quality issues
6. Overseeing CAPA processes and ensuring inspection readiness
7. Developing audit programs for clinical sites, CROs, and labs
8. Reviewing study protocols, reports, and regulatory submissions as needed
9. Collaborating with international partners
10. Developing budgets and tracking QA expenses

Qualifications include:

• Bachelor’s degree with 15+ years of related experience, including 8+ years in GCP/GLP/GVP quality roles
• Strong expertise in international GLP/GCP/PV regulations and experience with regulatory submissions
• Experience hosting and managing US and international inspections
• Ability to identify and resolve quality issues proactively
• Knowledge of relevant regulations such as 21CFR Part 11, ICH-GCP, HIPAA/data privacy
• Capacity to manage shifting priorities in a fast-paced environment
• Strong communication skills
• Willingness to travel domestically and internationally up to 20%

To apply, please fill out the application form including your first name, last name, email, phone, resume, LinkedIn profile, and website, and confirm your ability to work onsite in Boston 3-4 days per week.