GMP Operational Quality Senior Manager

About the role

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

Responsibilities

• Collaborates with internal 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 with 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
• Identifies and communicates risks and assists with risk mitigation plans as necessary
• Support internal audit or external audit programs

Knowledge and Skills

• 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
• Strong team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives
• In-depth 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 communicate cross-functionally to a wide variety of audiences; exchanges complex and sensitive information and is able to influence others to understand a point of view and gain alignment around a proposed action
• Demonstrated ability to work independently to provide QA advice for large, multifaceted projects
• Demonstrated ability to evaluate quality matters and make complex decisions leveraging technical experience and advanced judgement and the analysis/synthesis of a variety of information; able to work outside of precedent and takes a new perspective on existing solutions
• Strong experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPAS
• Strong experience with electronic document management systems (e.g., QDocs, Trackwise, Veeva)

Education and Experience

• Bachelor's degree in a scientific or allied health field (or equivalent degree)
• Typically requires 8 years of experience, or the equivalent combination of education and experience

Pay

Pay Range: $85-$90/hr