Director, Clinical Quality Assurance

Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company 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 metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. For more information, please visit www.seaporttx.com.

 

Seaport Therapeutics is seeking an experienced Director, Clinical Quality Assurance to manage GCP/GVP quality activities supporting clinical development programs, ensuring compliance with regulatory requirements and company policies.

This position will manage the development of risk assessments, audit programs, and the planning and resourcing audits. In addition, this role will lead or partner with clinical colleagues to prepare for GCP/GVP regulatory inspections. Other responsibilities include the provision of regulatory compliance and QA guidance to clinical and drug safety teams, review and provision of QA input into the related policies and procedures, and to lead training efforts for SOP and regulatory topics in the scope of responsibilities based on needs analysis.

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

· Develop, implement, and maintain QA GCP/GVP systems, risk management processes, and associated Policies and SOPs

· Ensure compliance of clinical development activities to applicable quality and regulatory requirements

· Provide updates and strategic recommendations to Clinical Management relating to GCP and GVP quality oversight and compliance

· Present Quality metrics on GCP/GVP aspects of all development and marketed programs at Quality Management Review meetings and provide recommendations for continuous improvement

· Ensure a risk-based approach to the identification and management of Quality issues

· Ensure suitability of corrective and preventive actions, verifying CAPAs to completion and keeping management informed of CAPA metrics

· Sponsor initiatives to ensure continuous improvement of QA systems

· Develop and maintain an audit program for clinical sites, CROs, and contract laboratories

· Review of clinical study protocols and reports, and regulatory submissions, as needed

· Oversee the GVP audit program and GVP inspections and ensure inspection readiness

· Support GLP quality and compliance of preclinical development activities as needed

· Develop budget forecasts and track QA expenses; Other duties as assigned

 

Qualifications

· Bachelor’s degree with 15+ years of related experience preferably in life sciences with 8+ years of experience in GCP/GVP Quality related roles, or equivalent experience

· Must have strong expertise in international GCP/GVP regulations and guidance with a strong emphasis on compliance and direct experience with regulatory submissions

· Must have direct experience hosting, leading and managing US and international inspections

· Proven ability to identify Quality issues/discrepancies through a risk-based approach and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner

· Knowledgeable of relevant regulations, including 21CFR Part 11, ICH-GCP, HIPAA/data privacy

· Experience in GLP Quality and knowledge of OECD regulations is a plus

· Must be able to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic environment

· Must have strong written and communication skills

· Ability to travel domestically and internationally up to 20%