Quality Manager for a technology firm specializing in supply chain visibility and risk management. Leading QMS initiatives and cross-functional teams for compliance and process improvement.
Responsibilities
Establishing, implementing, and ensuring continuous improvement of the organization’s Quality Management System (QMS)
Providing strategic leadership, operational oversight, and cross-functional coordination to ensure compliance with applicable standards, regulatory requirements, and internal business governance
Driving key initiatives through engagement with internal and external partners to meet strategic objectives and targeted outcomes
Leading the formation of workstreams to ensure process simplification, adoption, and operationalization, while establishing metrics to measure performance and ensure continuous improvement
Maintaining compliance with ISO 9001 and other relevant standards or regulations
Establishing quality objectives, KPIs, and monitoring mechanisms to measure system and process performance
Overseeing internal and external audits, ensuring findings are addressed through effective corrective and preventive actions
Managing external communications with customers, auditors, and regulatory bodies regarding quality matters
Facilitating cross‑functional problem‑solving, root cause analysis, and continuous improvement initiatives
Identifying opportunities to streamline processes, reduce waste, and improve system maturity
Overseeing the creation, approval, revision, and retention of controlled documents
Developing and delivering QMS training programs to ensure organizational understanding and compliance
Requirements
Bachelor’s Degree in a relevant field (Quality, Engineering, Life Sciences, Operations Management, Business or similar)
5+ years of experience in Quality Assurance working with Pharma, Life Sciences and/or Biotech
5+ years of experience leading global teams
Demonstrated experience managing an ISO 9001 aligned QMS
Master’s degree addressing strategic planning (Quality, Operations, Technology or similar)
Knowledge of GxP, ISO 9001, 21 CFR Part 11, EU Annex 11, ISO/IEC 17025
Experience in cold chain / supply chain monitoring or medical device industries
Experience with implementing and managing eQMS systems
Experience with validating software and hardware systems for support of regulated environments
Strong organization skills, with ability to lead multiple initiatives
Strong team leadership and communication skills
Strong problem solving and analytical skills
Experience collaborating with external partners
Experience in SaaS solutions or technology driven environments
Ability to travel up to 10% (domestic and international)
Benefits
Competitive starting base salary
Progressive advancement opportunity and career mobility
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