Operational Quality Manager (Contract) 889

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 or pharmaceutical environment, with experience in Quality Assurance, Quality Control, manufacturing operations, or analytical development.
• Experience should demonstrate a level of responsibility between individual-contributor QA oversight and senior technical-quality leadership.
• Experience supporting analytical method lifecycle activities, quality events, laboratory systems, and quality-system processes is required.

Required Knowledge, Skills & Competencies

• Strong knowledge of global regulatory expectations across the GxP lifecycle for Cell & Gene Therapy and/or biologics, including ICH, FDA, and EU requirements.
• Working knowledge of analytical development, method qualification, validation, verification, transfer, and stability activities.
• Knowledge of cGMP quality systems, including deviations, OOS investigations, CAPA, change control, risk management, and inspection readiness.
• Ability to apply risk-based thinking, critical thinking, and problem-solving to quality decisions and operational priorities.
• Demonstrated ability to lead quality-improvement projects using tools such as root-cause analysis, data analytics, Lean, DMAIC, or Six Sigma.
• Strong written and verbal communication skills, including technical review and quality-event documentation.
• Demonstrated ability to influence, collaborate, and build alignment across cross-functional teams in a matrix environment.

$70-$80/hr

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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