Product Compliance & Supplier Quality Consultant (Director)
Redbock - an NES Fircroft company, WorkFromHome, MA, United States
Our Client is a global biopharmaceutical company focused on discovering, developing, and commercializing immune‑modulating therapies for patients with debilitating diseases and significant unmet medical need.
Status: Hybrid-1 day WFH will be Friday
Contract Role: Product Compliance & Supplier Quality (GMP Manufacturing)
The contractor will support key Product Compliance and Supplier Quality activities including process, complaints, support with QMR and manufacturing operations include deviation review and documents associated with manufacturing operations.
Quality Department
The contractor will provide operational support within the client’s Quality Department, supporting Product Compliance and Supplier Quality activities related to manufacturing and supply chain operations. This role is execution‑focused and will contribute to the effective operation of the Quality Management System (QMS) while ensuring compliance with applicable regulatory and quality requirements.
Key Responsibilities
- Support Quality Department activities related to product compliance and supplier quality across manufacturing operations.
- Review and support manufacturing deviations , including documentation review, quality assessment, and follow‑up in accordance with established quality procedures.
- Support complaint handling activities , including documentation review and quality system workflow support.
- Assist with preparation, review, and maintenance of materials for Quality Management Reviews (QMRs) , ensuring accuracy, completeness, and timely updates.
- Support Supplier Quality activities, including documentation review and coordination with internal stakeholders to ensure supplier compliance with quality requirements.
- Draft, review, and maintain quality documentation associated with manufacturing operations, including SOPs, forms, records, and quality system artifacts.
- Partner cross‑functionally with Manufacturing, Supply Chain, and Quality stakeholders to support compliant execution of manufacturing activities.
- Ensure that quality records are complete, accurate, and maintained in compliance with the client’s Quality Management System.
- Support continuous improvement efforts within the Quality organization through participation in process updates and quality initiatives.
- Execute assigned activities in a timely manner while adhering to internal quality procedures and regulatory expectations.