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Senior Quality Manager Global Distribution

Company:
BIOBRIDGES LLC
Location:
Boston, MA, 02298
Posted:
May 31, 2025
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Description:

Job Title: Senior Quality Manager – GDP Operational Quality Duration: 12+ Month Contract Pay rate: $75/hr on W2 Are you a Quality professional passionate about global pharmaceutical distribution and GDP compliance?

We’re looking for a Senior Quality Manager – GDP Operational Quality to join a dynamic and fast-paced environment in Boston, MA (Hybrid) This role ensures medicines are distributed globally in compliance with GDP and GMP requirements while providing quality oversight for Third-Party Logistics (3PL) providers.

Key Responsibilities: Manage daily quality oversight of 3PL providers and ensure compliance with regulatory expectations Maintain and support the Quality Management System (QMS) for distribution operations Prepare and maintain Quality Agreements Handle deviations, CAPAs, change controls, and related documentation Conduct risk assessments and recommend mitigation strategies Maintain KPIs and support Management Review processes Support regulatory inspections, including planning, hosting, and follow-up CAPAs Collaborate cross-functionally with internal stakeholders and external partners Review and approve SOPs and other Quality documentation Support product complaint handling and ensure suppliers are appropriately approved Oversee licensing activities and mock recall preparedness Preferred Qualifications: Bachelor's degree in a scientific or allied health field 5+ years of experience in Quality roles within pharmaceutical or life sciences In-depth understanding of GDP and GMP compliance standards Strong communication, organizational, and problem-solving skills Proficiency in Microsoft Office (Word, Excel, PowerPoint) Auditing experience and qualifications are a plus

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