Analytical CMC Quality Senior Manager

This role is a temporary position with a third-party agency partner on assignment at Vertex Pharmaceuticals.

About the role

The Analytical CMC Quality Senior Manager is an advanced technical resource in the principles and application of quality assurance and compliance, responsible for quality oversight of Quality Control and analytical development activities of Cell & Gene programs. This includes release analytical testing, stability testing, and QA support for deviations and out-of-specification investigations, as well as QA oversight of technical analytical method validations and analytical transfer activities internally and at CDMOs through program life cycle management.

Responsibilities

• Analytical Lifecycle Management:
  • Serve as a Quality Assurance Subject Matter Expert for the QC domain and drive a culture of quality to assure compliance with FDA, EMA, and internal SOPs.
  • Lead QA review and approval of analytical development, qualification, validation, and analytical technical transfer activities.
• Compliance & Investigations:
  • Ensure proper root cause analysis (RCA) and Corrective and Preventive Actions (CAPA) for Out of Specification (OOS) and Out of Trend (OOT) results.
  • Perform/lead QA review and approval of QC-associated documentation, including deviation investigations, OOS, OOT, and change control.
• Digital & Artificial Intelligence:
  • Demonstrate understanding of digital quality systems, data management, automation, and emerging AI technologies within regulated GxP environments.
  • Leverage data analytics, digital tools, and AI-enabled solutions to improve quality oversight, operational efficiency, and decision-making.
• Quality Management Systems (QMS):
  • Support/lead QA risk management activities, including mitigation plans and associated execution.
  • Support development of Vertex quality systems and processes, draft/revise SOPs, policies, and work instructions.
  • Identify, facilitate, and/or lead continuous improvement efforts.
  • Ensure development of quality metrics at contract organizations that support excellence in quality systems.

Requirements

• Education:
  • Bachelor's degree in a scientific or allied health field (or equivalent degree).
  • Graduate degree preferred.
• Experience:
  • 8+ years of experience, or the equivalent combination of education and experience in a regulated pharmaceutical environment.
  • Prior experience working/running an internal analytical lab and working with external test labs.
  • Experience in analytical method development.
  • Experience with Root Cause Analysis, data analytics, and Operational Excellence methodologies (e.g., LEAN, DMAIC, Six Sigma).
• Skills & Knowledge:
  • In-depth global regulatory agency and technical knowledge across GxP QA and QC activities in cell therapies.
  • Broad understanding of regulatory environment including quality systems, compliance, and GMP regulations.
  • Experience with platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics is preferred.
  • Excellent communication skills and a proven track record influencing, building, and promoting a culture of Quality and Excellence.
  • Critical thinking and problem-solving skills.
• Other Requirements:
  • Up to 5% travel.

Pay

$90–$120/hour.