Director, Analytical Product Quality
Vertex Pharmaceuticals
June 30, 2026
On-site
Boston, MA
Operations
General/Position Summary
The Director of Analytical Product Quality provides quality oversight of analytical development activities throughout the product development lifecycle for Cell & Genetic therapy programs, including QA support for method validation and analytical transfer to contract manufacturers, test labs, and internal laboratories.
Key Duties & Responsibilities
- Maintain QA oversight of method development and qualification activities.
- Oversee the stability program to ensure compliance with internal procedures, EU/US regulatory standards, and cGMPs.
- Lead quality review of analytical development activities, including method qualification/validation protocols and reports.
- Support development of analytical strategy with cross-functional stakeholders.
- Drive investigations for out-of-specifications, root cause analysis, and CAPA implementation.
- Provide primary oversight for the reference standard program.
- Lead/participate in development of global Quality system standards and SOPs.
- Review/approve documentation, including deviation investigations and change control.
- Support regulatory submission review (e.g., INDs) and responses to regulatory questions as assigned.
- Identify compliance risks/gaps and implement mitigating controls.
- Support management of contract test labs, including Quality Agreements.
- Lead/participate in program quality/technical projects and continuous improvement aligned to FDA/EMA/SOPs.
Required Education
- BS/MS/PhD in engineering/Life Sciences or relevant equivalent background.
Required Experience
- Typically 10+ years in biotech/regulated pharma (manufacturing, QA, and/or QC).
Required Knowledge/Skills
- In-depth global regulatory/GxP knowledge for Cell & Gene therapy/Biologics; ICH and EU/FDA regulations.
- Analytical method development experience for cellular programs and clinical product development.
- Root Cause Analysis and Operational Excellence (LEAN, DMAIC, Six Sigma); risk management and strong communication/influencing.
Other Requirements
- Up to 5% travel.
The Director of Analytical Product Quality provides quality oversight of analytical development activities throughout the product development lifecycle for Cell & Genetic therapy programs, including QA support for method validation and analytical transfer to contract manufacturers, test labs, and internal laboratories.
Key Duties & Responsibilities
- Maintain QA oversight of method development and qualification activities.
- Oversee the stability program to ensure compliance with internal procedures, EU/US regulatory standards, and cGMPs.
- Lead quality review of analytical development activities, including method qualification/validation protocols and reports.
- Support development of analytical strategy with cross-functional stakeholders.
- Drive investigations for out-of-specifications, root cause analysis, and CAPA implementation.
- Provide primary oversight for the reference standard program.
- Lead/participate in development of global Quality system standards and SOPs.
- Review/approve documentation, including deviation investigations and change control.
- Support regulatory submission review (e.g., INDs) and responses to regulatory questions as assigned.
- Identify compliance risks/gaps and implement mitigating controls.
- Support management of contract test labs, including Quality Agreements.
- Lead/participate in program quality/technical projects and continuous improvement aligned to FDA/EMA/SOPs.
Required Education
- BS/MS/PhD in engineering/Life Sciences or relevant equivalent background.
Required Experience
- Typically 10+ years in biotech/regulated pharma (manufacturing, QA, and/or QC).
Required Knowledge/Skills
- In-depth global regulatory/GxP knowledge for Cell & Gene therapy/Biologics; ICH and EU/FDA regulations.
- Analytical method development experience for cellular programs and clinical product development.
- Root Cause Analysis and Operational Excellence (LEAN, DMAIC, Six Sigma); risk management and strong communication/influencing.
Other Requirements
- Up to 5% travel.