Senior Manager, GMP Operational Quality

Vertex Pharmaceuticals

GMP Operational Quality Senior Manager managing compliance projects. Collaborating with teams to resolve quality issues in biologics pharmaceutical manufacturing processes.

Posted 5/20/2026contractSeattle • Washington • 🇺🇸 United StatesSenior💰 $80 - $85 per hourWebsite

About the role

Key responsibilities & impact

Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions
Participates in cross-functional teams as an experienced Quality technical resource
Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex
Conducts quality investigations/deviations and reviews corrective action plans for adequacy and compliance
Maintains Quality Metrics to support process improvement activities
Approves investigations/CAPAs
Provides technical advice for partner and regulatory agency audits

Requirements

What you’ll need

Bachelor's degree in a scientific or allied health field (or equivalent degree)
Typically requires 6 years of experience, or the equivalent combination of education and experience
In-depth knowledge of both the conceptual and practical application of cGMPs in a biologics pharmaceutical setting
Strong experience managing complex projects with contract manufacturing organizations
Strong experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
Strong experience with electronic document management systems (e.g., QDocs, Trackwise, Veeva)

Benefits

Comp & perks

Compensation, medical benefits, and fringe benefits provided by third-party agency partner

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

cGMPRoot Cause AnalysisCAPAquality investigationscorrective action plansquality metricsprocess improvementproject managementquality agreements

Soft Skills

collaborationcommunicationleadershipproblem-solving