Vertex · 1 month ago
Associate Director, GMP Operational Quality (Biologics and Device Quality)
Boston, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
$154K/yr - $231K/yr
8+ years expVertex is a global biotechnology company that invests in scientific innovation. The Associate Director, GMP Operational Quality will provide leadership and quality oversight for contract testing laboratories supporting Vertex’s biologics and combination product portfolio, ensuring compliance with regulatory standards and data integrity throughout the product lifecycle.
Computer Software
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
Qualification
Required
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)
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
Benefits
Medical, dental and vision benefits
Generous paid time off (including a week-long company shutdown in the Summer and the Winter)
Educational assistance programs including student loan repayment
A generous commuting subsidy
Matching charitable donations
401(k)
Company
Vertex
Vendor intelligence that combs through your supplier, manufacturer, logistics data to detect where you're leaving money on the table.
2-10 employees
H1B Sponsorship
Vertex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (18)
2023 (7)
2022 (13)
2021 (5)
2020 (7)
Funding
Current Stage
Early StageCompany data provided by crunchbase