Senior Manager – Global Quality Systems

This is a fully remote position, open to applicants in Connecticut.

📋 Description

• Assist in the governance, effectiveness, and ongoing enhancement of the global Quality Management System (QMS)

• Promote harmonization, compliance, and operational excellence throughout global quality system processes

• Collaborate with process owners and cross-functional stakeholders to identify and mitigate quality system risks while ensuring readiness for inspections

• Oversee the global Management Review program, which includes planning, reporting, action tracking, and continuous improvement

• Create and maintain quality system Key Performance Indicators (KPIs), dashboards, and performance reports

• Prepare high-level executive reports on the health of the QMS, quality objectives, risks, and opportunities for improvement

• Track process effectiveness and implement enhancements that improve compliance, efficiency, and user experience

• Stay updated on evolving global regulations, standards, guidance documents, and industry best practices

• Conduct assessments of quality system impacts and gap analyses

• Formulate and monitor implementation plans for regulatory and standards requirements

• Collaborate with Regulatory Affairs and Quality leadership to assess regulatory requirements

• Lead due diligence in Quality Systems, integration planning, and QMS harmonization for acquisitions and strategic initiatives

• Evaluate quality system maturity, identify compliance gaps, and execute integration plans

• Aid in the implementation and optimization of electronic Quality Management Systems and related enhancement initiatives

• Support regulatory inspections, audits, and remediation efforts

• Guide, mentor, and develop the Quality Systems team

• Set performance expectations, prioritize resources, and promote quality, accountability, and continuous improvement

⛳️ Requirements

• Extensive working knowledge of MasterControl, Veeva, Trackwise, or comparable electronic Quality Management System (eQMS) platforms

• In-depth understanding of 21 CFR 820, ISO 13485, EU MDR, and MDSAP standards

• Proven ability to manage and develop teams effectively

• Capability to balance operational priorities alongside compliance requirements

• Strong organizational, analytical, and communication abilities

• Proficient in collaborating across global, cross-functional teams

• Over 8 years of experience in quality management systems within the regulated medical technology sector

• More than 7 years of experience in people leadership and team development

• Experience managing quality systems in accordance with ISO 13485, FDA 21 CFR Part 820, MDSAP, and EU MDR requirements

• A bachelor's degree in Engineering, Life Sciences, Quality, or a related field

• Standard office setting with regular use of computer systems and virtual collaboration tools

• May involve 20% domestic or international travel

🏝️ Benefits

• Medical coverage

• 401(k)

• Parental leave

• Fertility benefits

• Paid time off for vacation, personal, sick days, and holidays

• Numerous additional perks and benefits