Associate Director, GMP Operational Quality (Biologics and Device Quality)

Job Description

General Summary:

The Associate Director, GMP Operational Quality will provide leadership and quality oversight for contract testing laboratories (CTLs) supporting Vertex’s biologics and combination product portfolio across development, PPQ, launch, and commercial lifecycle management. This role ensures that analytical testing, method execution, and data generated by external laboratories meet Vertex, global regulatory, and data integrity standards.

Key Duties and Responsibilities:

• Serve as the primary QA lead for CTLs supporting release, stability, characterization, and device-related testing for Vertex’s biologics and combination products.

• Provide quality oversight for analytical method qualification/validation, method transfer, and lifecycle management activities executed by CTLs.

• Review and approve analytical protocols, reports, testing plans, stability protocols, and Quality Agreements.

• Ensure investigations (OOS/OOT/OOE), deviations, CAPAs, and change controls originating from CTLs meet Vertex standards and are compliant with global GMP expectations.

• Lead quality reviews, performance assessments, and risk management activities for the external testing network.

• Conduct or oversee QA review of analytical data packages, COAs, stability trending, device analytical outputs, and raw data from CTLs.

• Ensure compliance with ALCOA+ principles and global data integrity guidelines.

• Partner with Analytical Development and QC to evaluate method performance, assay robustness, and analytical control strategies.

• Provide QA input into specification setting, control strategy development, and analytical comparability assessments.

• Support analytical method development activities by ensuring appropriate QA oversight during method lifecycle progression.

• Provide QA support during method transfers, PPQ readiness, and commercial launch activities.

• Ensure CTLs are prepared to support global commercial supply, including alignment with international regulatory expectations.

• Contribute QA expertise to device-related analytical programs, including testing strategies for drug-device combination products.

• Support CTL audits and regulatory inspections involving analytical methods, testing, or device-related analytics.

• Maintain and update Quality Agreements, ensuring alignment with evolving program and regulatory needs.

• Drive continuous improvement in Vertex’s external testing oversight model, including procedures, metrics, and governance.

• Serve as a QA subject matter expert for analytical and device-related testing across biologics and combination product programs.

• Collaborate with CMC, Analytical Development, QC, MS&T, Device Engineering, QA Device, and Regulatory Affairs to ensure robust analytical control strategies.

• Represent QA in analytical lifecycle teams, technical forums, and program governance meetings.

Knowledge and Skills:

• Demonstrated experience overseeing contract testing laboratories supporting biologics, sterile products, or combination products.

• Strong understanding of analytical method development, validation, transfer, and lifecycle management.

• Knowledge of biologics analytical control strategies, immunoassays, cell-based assays, potency assays, and device analytical requirements.

• Familiarity with combination product regulations (21 CFR Part 4), global GMPs, and data integrity expectations.

• Experience supporting clinical development through commercial supply, including PPQ, launch readiness, and post-approval changes.

• Excellent leadership, communication, and influencing skills in a highly matrixed environment.

• Experience with electronic document management systems (e.g., Veeva)

Education and Experience:

• Bachelor's degree in a scientific or allied health field (or equivalent degree)

• Typically requires 8+ years of work experience, or the equivalent combination of education and experience

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Pay Range:

$154,100 - $231,200

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.