Leads GMP operational quality activities for biologics and pharmaceutical devices, including drug product disposition, quality investigations, deviations, CAPA, change controls, batch record review, quality agreements, audits, risk mitigation, and GMP document approval. Partners with contract manufacturers and cross-functional teams to resolve complex compliance issues and improve quality systems. This is a one-year contract with possible extension.
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
Requirements
- 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)
Benefits
1 year contract with possible extension
Administrative shift
BioPharma Consulting JAD Group Cambridge, Massachusetts, USA Office
PO Box 425233, Cambridge, MASSACHUSETTS, United States, 02142
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