GMP Operational Quality Assurance Manager

1w1 week ago

Vertex Pharmaceuticals

Boston, US · Full-time · $140,000 – $160,000

About this role

The Quality Manager is a technical resource in the principles and application of quality assurance, quality systems, and compliance. This role coordinates or executes activities on a wide range of projects and takes part in designing new projects. It ensures alignment with corporate goals and compliance with regulatory requirements, reporting to the GMP Operational Quality Senior Manager.

Day-to-day involves providing QA support for change controls, investigations, CAPAs, and effectiveness checks. Perform Batch Record Review and Lot Disposition for Health Donor, Critical Components, and Drug Product lots. Draft, review, and manage approval of quality system documentation like deviations and SOPs.

Collaborate with internal groups, external CDMOs, and cross-functional teams to resolve issues and meet metrics. Lead meetings, represent Vertex Quality, and manage activities for Quality Assurance Associates or Specialists. Partner on continuous improvement and support regulatory inspections.

Act as subject matter expert in quality improvements, collect metrics data, and identify risks to meet business needs. Participate in inspection readiness and on-site support for regulatory and internal audits. Influence teams in a fast-paced GMP environment.

Requirements

Relevant experience in Quality Assurance, Quality Operations, or a related GMP-regulated function within biotechnology, pharmaceuticals, or advanced therapies
Demonstrated experience supporting GMP operations in a manufacturing or operational quality environment
Strong understanding of quality systems, including deviations, CAPA, change control, investigations, and document management
Knowledge of applicable regulatory requirements and industry expectations for GMP environments
Experience working cross-functionally and influencing teams in a complex operational setting
GMP / cGMP compliance
Quality systems management

Responsibilities

Collaborate with internal and external business partners to resolve quality issues ensuring compliant solutions
Provide QA support of change controls, investigations, CAPAs, and effectiveness checks
Draft, review, and manage approval of quality system documentation including deviations, change controls, and CAPAs
Perform Batch Record Review of Health Donor and Drug Product lots
Perform Lot Disposition of Critical Components and Drug Product lots
Partner with External CDMOs
Support regulatory agency inspections including inspection readiness activities
Manage day-to-day activities for a Quality Assurance Associate(s)/Specialist(s)