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RoslinCT · 22 hours ago

Sr. Manager QA, Supplier Quality

Hopkinton, MA

Full-time

Hybrid

Senior Level, Lead/Staff

$130K/yr - $170K/yr

8+ years exp

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization. The Senior QA Manager, Supplier Quality is responsible for managing and developing Supplier Quality Programs, conducting Supplier Audits, and ensuring compliance with quality standards while promoting a quality culture within the organization.

BiotechnologyClinical TrialsManufacturing

Hiring Manager

Stacy Adams Coburn

Responsibilities

Manage and further develop the Supplier Quality Program

Manage and conduct Supplier Audits

Manage the Supplier Qualification activities including classification evaluation, quality agreements and quality questionnaires; further development with peers

Manage Supplier Change Notification (SCN) Program

Manager Supplier Corrective Action Requests and Notifications (Support creation and management of supplier investigations)

Develop programs, workflows and standard operating procedures for the Supplier Quality program

Monitor implementation of Supplier Quality programs, ensuring compliance to SOPs and identifying areas for improvement

Support implementation and training of associated systems

Act as Supplier Quality SME for NCMRs (Non-conforming Material Requests)

Assist Quality Systems during health authority inspections and client audits

Review/Approve Deviations, Change Controls and CAPAs as necessary

Contribute to development of Key Performance Indicators that measure effectiveness of QMS and assist with tracking and trending of Supplier Quality data

Support reporting of KPls as part of Quality Management Review

Mentor personnel within QA and cross functionally on Supplier Quality Systems to promote a quality culture

Other duties as assigned

Qualification

Supplier Quality experienceQuality Audit certificationsCGMPICH regulationsQuality Systems implementationContinuous improvement initiativesMicrosoft Office SuiteOralProblem-solving capabilitiesWritten communicationTeam orientedMentoring personnel