Director, GMP QA Analytics – Biologics Compliance

Vertex Pharmaceuticals; Boston (MA); Hybrid; USD 154,000 - 231,000; Full time

Job summary

Vertex seeks a senior Quality Compliance leader to oversee regulatory and quality program alignment for biologics development. You will manage a Quality staff, review analytical data, and guide investigations and change controls while coordinating with Quality Disposition teams for product release and C of A approvals.

Reporting to the Director, GMP Operations Quality, this hybrid role requires onsite presence at Boston, MA, with responsibility for data reviews, method validation, and regulatory

Qualifications

• Master's degree and 5-8 years of relevant work experience, or Bachelor's degree in a scientific or allied health field (or equivalent degree) and 10+ years of relevant work experience, or relevant comparable background
• Successful people management
• Previous experience with product stability programs

Responsibilities

• Manage Quality staff to collaborate with cross functional technical groups on product stability programs.
• QA review of Analytical data in support of Clinical development programs.
• Support all analytical related deviations and investigations, OOS, OOTs as applicable. Lead Material Review Board discussions, as necessary
• Issuance of Stability reports upon request
• Review of RSS and Shipping Excursion Study Reports
• Oversee and conduct method validation/ transfer data review, for Clinical reference standard programs.
• Review and approve Method Validation and transfer Protocols/reports generated internally and externally.
• Support investigations and QA guidance for complex investigations
• Coordinate with Quality Disposition teams to ensure review and reporting of product release data
• Perform Compliance review of data in support of disposition of Clinical product
• Resolve issues with CMO or internal technical teams
• Approve Certificate of Analysis
• Review and approve stability trend reports in a timely manner
• Identify and discuss stability trends with management
• Product Transition to Commercial / Registration to Validation / PAI Readiness
• Evaluate CMO Quality Systems to ensure compliance with commercial expectations
• Provide onsite support for critical batches
• Test Articles Oversight
• Review of Test Article production records
• Review of Test article data
• Approval of Test article C of A
• Change Controls- execution
• Owner /Assessor of Change controls
• QA Approver work with technical teams to resolve gaps and approve change plans and classification
• Supporting deployment of QMS (GMP Rep)
• Generate Performance updates for presentation to QMT, QLT, EQLT as needed
• Gap/Risk communication
• Metric analysis
• Participate on process improvement initiatives
• Performance Management/ Individual Development/ Training
• Goals development
• Perform performance reviews
• Create Individual Development Plans in conjunction with employee
• Timely completion of training requirements prior to execution

Skills

Product stability

People management

Analytical data review

Quality systems

Education

Master's degree

Bachelor's degree in science

Job description

Vertex seeks a senior Quality Compliance leader to oversee regulatory and quality program alignment for biologics development. You will manage a Quality staff, review analytical data, and guide investigations and change controls while coordinating with Quality Disposition teams for product release and C of A approvals.

Reporting to the Director, GMP Operations Quality, this hybrid role requires onsite presence at Boston, MA, with responsibility for data reviews, method validation, and regulatory