GMP Operational Quality Senior Manager

Biopharma-Consulting-Jad-Group; Boston (MA); On-site; USD 140,000 - 180,000; Full time

Job summary

Vertex seeks a GMP Operational Quality Senior Manager to lead QA activities, ensuring compliance across drug products and devices. This role coordinates complex projects, focusing on GMP disposition and quality systems improvements.

The candidate will drive investigations, CAPA and risk management, review batch records, and support audits. A strong background in cGMPs, biopharma manufacturing, and vendor quality is essential.

Qualifications

• In‑depth knowledge of both conceptual and practical cGMPs in biologics + devices pharmaceutical setting.
• Experience managing complex projects with CMOs and continuous improvement within timelines.
• Experience with quality risk management best practices.

Responsibilities

• Collaborate with internal and external partners to resolve complex quality issues to ensure compliant solutions.
• Participate in cross‑functional teams as a seasoned quality technical resource.
• Draft and enforce quality agreements between CMOs/Suppliers and Vertex as needed.
• Assist Change Control owners with ensuring compliance to change procedure requirements.
• Initiate and assess change controls.
• Conduct quality investigations/deviations and review CAPA plans for adequacy and compliance.
• Ensure CAPA actions are identified and addressed.

Skills

Quality management

GxP knowledge

CAPA

Root cause analysis

Risk assessment

Documentation reviews

Education

Bachelor's degree in a scientific or allied health field

Tools

QDocs

Trackwise

Veeva

Job description

The GMP Operational Quality Senior Manager is an advanced technical resource in the principles and application of quality assurance and compliance. This role coordinates or executes activities on multiple complex projects with emphasis on QA GMP disposition of drug products and devices.

Responsibilities

• 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. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS.
• Ensures appropriate CAPA actions are identified and addressed.
• Approves investigations/CAPAs.
• Performs review and approval of master and executed batch records to support drug substance (DS), drug product (DP) and finished goods (FG) disposition 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
• Identify and communicate risks and assist with risk mitigation plans as necessary
• Supports internal audit or external audit programs

• Bachelor's degree in a scientific or allied health field.
• 8 years of experience.

Must have

• In- depth knowledge of both the conceptual and practical application of cGMPs in a biologics + devices pharmaceutical setting; in-depth knowledge of global GMP requirements in support of GMP Drug Product manufacturing
• Experience managing complex projects with contract manufacturing organizations and continuous improvement within stated objectives and timelines
• Experience in identifying, assessing and mitigating potential risks utilizing quality risk management best practices
• Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
• Experience with electronic document management systems (e.g., QDocs, Trackwise, Veeva)

1 year contract with possible extension

Administrative shift