Senior Quality Manager-Global Distribution

Company: BIOBRIDGES LLC
Location: Boston
Posted on: June 4, 2025

Job Description:

Job Title: Senior Quality Manager - GDP Operational Quality

Maximise your chances of a successful application to this job by ensuring your CV and skills are a good match.
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

Keywords: BIOBRIDGES LLC, Portland , Senior Quality Manager-Global Distribution, Professions , Boston, Maine