Supply Chain Operations - Life Sciences Manufacturing Quality - Manager

Location:

Anywhere in Country

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Client-facing Life Sciences Manufacturing Quality Manager who leads technology-enabled transformation work streams that strengthen quality systems, compliance, audit and inspection readiness, and product quality across manufacturing and laboratory operations. The role combines practical quality-domain knowledge with digital QMS, data, AI, and delivery skills to turn quality needs into solutions that work in regulated environments.

As a Manager in Supply Chain Manufacturing Quality, you will work with pharmaceutical, biotechnology, and medical-device manufacturers to improve how quality, QA/QC, laboratory, manufacturing, and technology teams operate together. You will lead defined work streams from assessment and requirements through solution design, implementation, testing, adoption, and stabilization, with a focus on quality-system performance, data integrity, and inspection readiness.

This is a techno-functional delivery role. You will facilitate decisions with client quality and laboratory teams, translate quality and lab needs into actionable requirements, coordinate functional and technical specialists, and take ownership of the quality and progress of your workstream. You will contribute to broader program planning and value realization while working with senior engagement leaders on cross-program decisions and commercial matters.

• Lead client-facing work streams in Life Sciences Manufacturing Quality transformation, with clear ownership of plans, deliverables, risks, decisions, and outcomes.
• Assess current-state quality processes, user needs, system landscapes, data flows, performance gaps, and site constraints through workshops, data analysis, and quality and laboratory engagement.
• Translate priorities such as right-first-time execution, cycle-time reduction, deviation and nonconformance reduction, CAPA effectiveness, and inspection readiness into process designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for relevant quality capabilities such as deviations/nonconformances and investigations, CAPA, change control, complaints, audits and inspection readiness, supplier quality, batch disposition/release and review by exception, and quality risk management.
• Coordinate integration requirements across eQMS/QMS, LIMS, MES/MOM, ERP, document-management, and laboratory-instrument and informatics systems, working with architecture, quality-systems, and cybersecurity specialists.
• Define and review data mappings, batch and investigation context, master-data needs, interface specifications, and data-quality controls needed for quality reporting, analytics, and AI use cases.
• Help deliver quality analytics and AI use cases, such as AI-assisted investigation and root-cause analysis, anomaly and trend detection, predictive quality, and quality decision support, by assessing data readiness, workflow fit, evaluation criteria, and human-in-the-loop review, governance, and controls.
• Work with client quality and validation teams to reflect applicable GxP/GMP, data-integrity, electronic-records-and-signatures, controlled-change, and validation or risk-based assurance requirements, including audit trails and traceability, in workstream deliverables.
• Oversee configuration activities and lead functional testing, defect resolution, deployment readiness, training, cutover support, hypercare, and handover for your workstream.
• Facilitate working sessions across quality, QA/QC,…