Operational Quality Manager (Contract) 889

Vertex Pharmaceuticals•Boston, MA

20d•$70 - $80•Onsite

About The Position

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 ensures analytical method lifecycle, stability, quality-event, and laboratory-data activities comply with applicable cGMP requirements, Vertex quality systems, and relevant EU and US regulatory expectations. The QA Manager partners with Quality Control, Analytical and Process Development, Manufacturing, and MSAT to identify and mitigate quality risks, resolve compliance issues, and support product-development and operational milestones. The position combines technical QA execution with leadership of quality initiatives and development of team capability, supporting internal and external programs. The role is on-site five days per week, with ad hoc flexibility; time is split 50% between the internal T1D program and 50% between the external LPO T1D program. Minimal travel may be required to support technology transfer.

Requirements

Bachelor’s degree in biotechnology, life sciences, engineering, or a related field.
At least 5 years of relevant industry experience, such as manufacturing, quality assurance, and/or quality control in a biotechnology or regulated pharmaceutical environment.
Progressive relevant industry experience in a regulated biotechnology or pharmaceutical environment, with experience in Quality Assurance, Quality Control, manufacturing operations, or analytical development.
Experience supporting analytical method lifecycle activities, quality events, laboratory systems, and quality-system processes.
Strong knowledge of global regulatory expectations across the GxP lifecycle for Cell and 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 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.
On-site presence five days per week; minimal travel may be required to support technology transfer.

Nice To Haves

Master’s degree or comparable relevant background.
QC expertise, including experience with flow cytometry assays, cell-based assays, method validation, technology transfer, and analytical investigations.

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 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 and US regulatory standards.
Identify compliance risks, quality-system gaps, and continuous-improvement opportunities; partner with stakeholders to implement 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, providing quality input, assessing proposed changes, and promoting 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 documentation preparation 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.