Senior GMP Operational Quality Manager – Vendor Management

Vertex Pharmaceuticals

Senior Manager of GMP Operational Quality at Vertex Pharmaceuticals managing vendor-related quality issues. Overseeing quality compliance, investigations, and process improvements in the pharmaceutical setting.

Posted 7/10/2026contractSeattle • Washington • 🇺🇸 United StatesSenior💰 $80 - $85 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates in-depth knowledge of cGMPs and global GMP requirements in a biologics pharmaceutical setting, with strong capabilities in quality risk management, project management, and compliance oversight. Proven ability to lead investigations, mentor colleagues, and communicate effectively across functions.

Highest-signal resume keywords

In-Depth Knowledge Of cGMPsQuality Risk ManagementEvent Investigations And Root Cause AnalysisProject Management With CMOsElectronic Document Management Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality InvestigationsCorrective Action Plans (CAPA)Change Control ManagementQuality Metrics MaintenanceGMP Document Review

Soft Skills

Team LeadershipMentoring And Guiding ColleaguesCross-Functional CommunicationIndependent Problem Solving

Tools & Technologies

QDocsTrackwiseVeeva

Industry Keywords

Biologics PharmaceuticalGMP ManufacturingQuality AgreementsCompliance SolutionsRisk Mitigation Plans

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, as needed
Assists Change Control owners with ensuring compliance to change procedure requirements
Initiates and assesses change controls
Conducts quality investigations /deviations and reviews corrective action plans for adequacy and compliance
Ensures appropriate CAPA actions are identified and addressed
Performs review and approval of master and executed batch records to support drug substance (DS), drug product (DP) and finished goods (FG) disposition activities
Maintains Quality Metrics to support process improvement activities
Provides tactics to address compliance gaps or recommends enhancements to cross-functional quality systems
Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports
Responsible for coordinating, facilitating and follow up on any QLT action items assigned
Identify and communicate risks and assist with risk mitigation plans as necessary
Supports internal audit or external audit programs
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
In-depth knowledge of global GMP requirements in support of GMP manufacturing
Strong team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives
Strong experience managing complex projects with contract manufacturing organizations and continuous improvement within stated objectives and timelines
Strong experience in identifying, assessing and mitigating potential risks utilizing quality risk management best practices
Ability to mentor and guide less experienced colleagues, skilled at transferring technical knowledge and teaching quality management skills
Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex and sensitive information
Demonstrated ability to work independently to provide QA advice for large, multifaceted projects
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, fringe benefits, and other terms presented by the third-party agency partner