Associate Director, GMP Operational Quality, Cell & Gene (Wed - Sat, Second Shif

Associate Director, GMP Operational Quality, Cell & Gene (Wed - Sat, Second Shift)

Join to apply for the Associate Director, GMP Operational Quality, Cell & Gene (Wed - Sat, Second Shift) role at Vertex Pharmaceuticals

Job Description

The Associate Quality Director conducts quality assurance oversight and management activities of clinical trial operations to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols, and Vertex policies and procedures. These activities include the development and execution of study level audit plans, accurately identifying and communicating compliance risks, overseeing action plans to mitigate risks, monitoring quality issues and compliance metrics, investigation and CAPA management, and proactive inspection readiness activities.

Location and Shift

This role is located at Vertex’s Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA-02210. It is a second shift role from Wednesday to Saturday, 12:30 PM to 11:00 PM.

Key Duties & Responsibilities

• Leads a team responsible for internal commercial operations supporting GMP manufacturing and testing activities, including disposition of intermediates, working cell banks, and clinical and commercial drug products at Vertex facilities.
• Serves as the Quality Lead for assigned clinical programs, providing GCP compliance interpretation, consultation, and support to maintain and improve research quality, ensuring subject safety, rights, well-being, and data integrity.
• Maintains current knowledge of industry standards and methodologies related to GCP.
• Coordinates with Vertex clinical functions and external parties such as CROs, vendors, and investigator sites to promote high-quality standards and consistency.
• Reviews protocols and participates in Operational Review Boards to identify operational risks and develop mitigation strategies.
• Develops and manages risk-based audit plans, conducts audits, reviews reports, and evaluates responses and CAPA plans.
• Leads domestic and international audits to ensure compliance with ICH GCP, regulations, and standards.
• Investigates quality issues, performs root cause analysis, and develops CAPA, assisting study teams in implementing corrective actions.
• Contributes to continuous quality improvement initiatives and inspection readiness activities.
• Provides inspection support for regulatory agency inspections at Vertex or investigator sites.
• May serve as GCP Quality Management System representative and review SOPs/WIs.
• Analyzes KPI data and trends, proposes remedial actions, and participates in process improvements.
• Maintains QA relationships with GCP vendors and participates in Vendor Joint Operating Committees.

Qualifications

• Bachelor's degree in biotech/life sciences; master's degree or relevant experience preferred.
• 7+ years in manufacturing, quality assurance, or quality control in biotech/pharma environment.
• Deep knowledge of ICH GCP R2, global regulations (FDA, EU, MHRA), and clinical development processes.
• Experience with event management, investigation, root cause analysis, CAPA, and metrics analysis.
• Excellent communication skills, ability to work independently, manage complex projects, and proficiency in Microsoft Office.

Additional Requirements

• Up to 5% travel may be required.

Compensation and Benefits

Pay range: $154,100 - $231,200. Role is eligible for bonuses, equity, and comprehensive benefits. Flexible work options available as per company policy.