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Sr. Clinical QA Specialist
Position Summary:The Clinical Quality Assurance (QA) Specialist is responsible for ensuring the quality and compliance of clinical studies and activities in accordance with applicable regulatory requirements, including FDA 21 CFR Part 812, ICH GCP, ISO 14155, and company SOPs. This role supports the development, execution, and continuous improvemen...
Senior Manager, Quality Assurance
Senior Manager, Quality AssuranceJoin a Leading Medical Device Manufacturing Team in Boston, MAAre you an experienced Quality Assurance professional ready to take a leadership role in a regulated environment? We are seeking a Senior Manager, Quality Assurance to oversee quality operations at our client's manufacturing site in Boston, MA. Reporting ...
Director, Clinical Quality
Title: Director, Clinical QualityLocation: Hybrid/Flexible in Boston (Must be in MA) Position OverviewThe Director of Clinical Quality is responsible for leading Clinical Quality Assurance (CQA) activities for assigned clinical development programs. This role oversees audits, manages quality issues, conducts investigations, and ensures inspection r...
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Director, GMP Quality
Title: Director, Quality (GMP)Location: Cambridge, MA (Hybrid) Position SummaryThe Director of Quality & Compliance (GMP) plays a vital leadership role within the Quality & Compliance function, providing operational, regulatory, and system-level expertise for GMP-related activities. This individual will ensure that all GMP efforts-whether executed ...
Associate Director/Director, Quality & Compliance
Title: Associate Director/Director, Quality & Compliance Location: Greater Boston Area (On-site) A local pharmaceutical company is seeking an Associate Director or Director of Quality to lead their growing team! This is a great opportunity for anyone looking to step into a Quality leadership role: Responsibilities:Ensure all finished products meet ...
Quality Assurance Consultant
The Contractor, Product Quality is responsible for supporting GMP manufacturing, release, stability, and validation activities associated with development and commercialization of small-molecule assets. This function operates within a virtual (100% outsourced) business model will support batch disposition of drug substance, drug product, packaging,...