Operational Quality Manager

The QA Manager (Contractor), Analytical Product Quality provides hands-on Quality Assurance oversight for analytical development and Quality Control activities supporting Cell and Genetic Therapy programs. The role is responsible for ensuring analytical method lifecycle, stability, quality-event, and laboratory-data activities are performed in compliance with applicable cGMP requirements, Vertex quality systems, and relevant EU/US regulatory expectations.

The QA Manager partners closely with Quality Control, Analytical/Process Development, Manufacturing, and MSAT to identify and mitigate quality risks, resolve compliance issues, and support product-development and operational milestones. This role combines technical QA execution with leadership of quality initiatives and development of team capability and will support internal and external programs.

*** The ideal candidate will be a QC expert including experience with flow cytometry assays, cell based assays, method validation, tech transfer and analytical investigations ***

This is an on-site role requiring presence five days per week, with ad hoc flexibility. 50% time allocated to internal T1D program and 50% time allocated to external LPO T1D program. Minimal travel may be required to support tech transfer.

Key Duties & Responsibilities

• Provide proactive, hands‑on QA oversight of analytical development and Quality Control laboratory activities, including method qualification, transfer, verification, and validation.
• Review and approve analytical lifecycle documentation, including protocols, reports, assay packets, LIMS master data, LES data, deviations, change controls, risk assessments, and investigation reports.
• Lead and support the investigation, assessment, trending, and timely closure of QC‑related quality events, including out‑of‑specification (OOS) investigations.
• Ensure appropriate data verification and compliance review for deviations, root‑cause analyses, CAPA activities, and change controls.
• Maintain QA oversight of stability‑program activities to ensure compliance with Vertex procedures, cGMPs, and EU/US regulatory standards.
• Identify compliance risks, quality‑system gaps, and continuous‑improvement opportunities; partner with stakeholders to implement effective mitigating controls and actions.
• Support development, implementation, and maintenance of analytical quality standards, procedures, training materials, and best practices.
• Participate in cross‑functional Cell and Genetic Therapy projects and governance forums to provide quality input, assess proposed changes, and promote standardized and compliant processes.
• Support preparation and review of relevant sections of regulatory submissions and responses to regulatory questions, as assigned.
• Support readiness for health‑authority inspections and information requests, including preparation of documentation and follow‑up actions.
• Support contract testing laboratory management activities, including development and review of Quality Agreements.
• Lead or participate in quality and technical improvement projects using root‑cause analysis, data analytics, and operational‑excellence approaches.
• Provide day‑to‑day coaching, technical guidance, and mentorship to QA team members and cross‑functional partners, helping build a culture of Quality and Excellence.

Required Education

• Bachelor’s degree in a biotechnology, life sciences, engineering, or related field.
• Master’s degree or comparable relevant background preferred.
• 5+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment

Required Experience

• Typically requires progressive relevant industry experience in a regulated biotechnology…