Director, Analytical Product Quality

General/Position Summary

The Director of Analytical Product Quality, is responsible for the quality oversight of analytical development activities throughout the product development lifecycle for Cell & Genetic therapy programs. This role includes Quality Assurance support to cross-functional partners for the method validation of applicable analytical methods and support on analytical transfer activities to contract manufacturers, test labs and internal laboratories as applicable.

The role will closely partner with operational stakeholders to participate in Cell & Genetic therapies projects to meet business, regulatory and operational requirements.

Key Duties & Responsibilities

• Proactively maintain Quality Assurance oversight of the method development, and qualification activities for the applicable methods/program.
• Responsible for the QA oversight of the stability program to assure compliance with internal Vertex procedures and EU/US regulatory standards. Ensure compliance with cGMPs.
• Lead quality review for analytical development activities, analytical method qualification/validation protocols and reports including associated approval.
• Supports development of the program analytical strategy with cross-functional stakeholders.
• Drive investigations for out of specifications, root cause analysis and effective corrective and preventive actions implementation.
• Primary quality oversight of the reference standard program for the applicable methods.
• Lead/participate in the development of Vertex global Quality system standards and SOPs.
• Review and approve relevant documentation including deviation investigations and change control.
• Support review of relevant sections of regulatory submissions including IND’s as assigned; Assist in responses to regulatory questions where applicable.
• Responsible for identifying compliance risks and gaps, and associated execution for the implementation of mitigating controls.
• Support contract test labs management process including the creation and review of Quality Agreements.
• Lead/ participate in Cell & Genetic Program Quality & technical projects and drive continuous improvement activities as assigned by Management. Ensure activities and deliverables are in compliance with FDA, EMA, SOPs and industry best practices.

Required Education Level

• Bachelor's degree, Master's degree, or PhD in an engineering/Lifesciences field or relevant comparable background

Required Experience

Typically requires 10+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.

Required Knowledge/Skills

• In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics, broad knowledge of ICG Guidelines, EU/FDA regulations.
• Experience in method development for cellular programs, clinical product development and analytical method development
• Broad understanding of regulatory environment including quality systems, compliance and strategy for Cell & gene technology
• Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
• Ability to apply risk management principles to decision making and operational priorities.
• Critical Thinker and Problem Solver
• Strong influencing skills and an innate ability to collaborate and build relationships

Other Requirements

Up to 5% travel