Operational Quality Manager (Contract) 889

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 96,000 - 110,000; Full time

Job summary

Vertex Pharmaceuticals LLC in Boston, MA is seeking a QA Manager (Contractor) to provide hands‑on QA oversight for analytical development and Quality Control within Cell and Genetic Therapy programs.

The role partners with Quality Control, Analytical Development, Manufacturing and MSAT to mitigate risks, resolve compliance issues, and support product development milestones while leading quality initiatives and building team capability.

Qualifications

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

Responsibilities

• Provide QA oversight of analytical development and Quality Control activities, including method qualification, transfer, verification, and validation.
• Review and approve analytical lifecycle documents such as protocols, reports, and deviation investigations.
• Lead investigations and CAPA activities for quality events and OSI investigations.
• Ensure data verification and compliance review for deviations, root‑cause analyses, CAPA, and change controls.
• Maintain QA oversight of stability programs and regulatory standards across Vertex processes.
• Identify compliance risks and drive continuous improvement with stakeholders.
• Develop and maintain analytical quality standards, procedures, and training materials.
• Participate in cross‑functional Cell and Genetic Therapy projects and governance forums.
• Prepare and review regulatory submission sections as assigned.
• Support readiness for health‑authority inspections and information requests.
• Support contract testing laboratory management and Quality Agreements.
• Lead quality and technical improvement projects using RCA, data analytics, Lean, and Six Sigma.
• Mentor QA team and cross‑functional partners to foster a culture of Quality.

Skills

Quality Assurance

cGMP

Risk management

Regulatory knowledge

Leadership

Cross-functional collaboration

Root-cause analysis

Data analysis

Education

Bachelor’s degree in biotechnology, life sciences, engineering, or related field

Master’s degree or comparable background preferred

5+ years in biotechnology/pharma quality environment

Job description

Job Description

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.

Pay Range

$70-$80/hr