Vice President, Quality

Seaport Therapeutics is seeking a talented Vice President, Quality to establish, lead, and oversee the company’s Quality organization, ensuring compliance with GMP, GCP, and GLP requirements. This senior leadership role is essential in developing the company’s Quality Management Systems (QMS), ensuring alignment with international regulatory standards, and driving initiatives that support the organization’s strategic objectives.

The incumbent will be required to work flexibly across a number of drug development programs with responsibilities for all aspects of Quality Assurance. The VP Quality is responsible for leading and managing all Seaport Therapeutics Quality Assurance (QA) programs, activities, and staff to ensure compliance with global laws, regulations and applicable guidance. The overall responsibility of this role is to design and execute strategic and tactical guidance for GxP (Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP)) and compliance for manufacturing, distribution, test laboratories and clinical trial activities.

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 Chief Operating Officer (COO).

Seaport Therapeutics has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary Glyph TM 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

Responsibilities

Strategic Quality Leadership:

• Define and implement the organization’s strategic quality vision, ensuring alignment with corporate goals.
• Provide strategic Quality input to support company objectives and milestones.

Quality Management Systems (QMS):

• Design, implement, and maintain robust GxP programs and frameworks, including QMS, SOPs, training programs, and issue management processes.
• Lead continuous improvement initiatives to enhance Quality processes and infrastructure.

Regulatory Compliance and Audit Preparation:

• Act as the primary point of contact with regulatory agencies and external auditors, fostering trust in the company’s quality systems.
• Prepare for and lead regulatory inspections, ensuring compliance with applicable regulations and standards.
• Ensure the completion of scheduled third-party audits by internal QA staff or external contractors.
• Ensure that company and departmental SOPs, job descriptions, and training documentation are current, relevant, and appropriately maintained.
• Process Improvement and Risk Management:
• Oversee the development, maintenance, and enhancement of processes, including Quality Event and CAPA management.
• Develop and execute risk-based audit strategies to ensure compliance with ICH/GCP guidelines and regulatory requirements.
• Identify and address process gaps or failures, implementing appropriate corrective actions.
• Cross-Functional Collaboration:
• Promote a GxP-compliant culture across internal teams and external stakeholders.
• Provide expertise in interpreting and implementing regulations to assure compliance.
• Metrics and Reporting:
• Develop and analyze Quality-related metrics and provide actionable insights.
• Escalate GCP corporate risks, scientific misconduct, or noncompliance issues to resolution.
• Leadership and Team Management:
• Recruit, develop, and manage a high-performing, phase-appropriate Quality team.
• Foster a collaborative, innovative, and compliant work environment.
  

Qualifications

• Bachelor's degree in Science or related field; advanced degree preferred
• At least 15 years of experience in the pharmaceutical or biotechnology industry, with significant expertise in Quality or a related function
• Minimum of 8 years of Quality leadership/management experience in director or higher-level position
• Strong knowledge of GxP and regulatory requirements, with hands-on experience implementing and managing Quality systems
• Strong preference for hands-on experience building and implementing Quality Management System in biotech startup company with clinical-stage portfolio
• Strong organizational, analytical, and problem-solving skills, with the ability to manage multiple priorities in a dynamic environment
• Proven ability to foster cross-functional collaboration and build relationships at all organizational levels
• Superior team leadership, communication, collaboration, and problem-solving skills
• Experience in all phases of regulatory submissions and interactions; international experience desired
• Experience with documentation systems and with document review and auditing
• Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards
• Extensive experience handling health authority inspections
• Small molecule drug development experience highly desirable
• Experience in overseeing or participating in GMP audits and building team for batch review and release
• Experience in overseeing or participating in GCP audits; experience including external CRO, clinical/regulatory and document auditing desirable