Senior Manager-Global Quality Systems

Scope:

The Senior Manager Global Quality Systems provides leadership and oversight for key elements of CooperSurgicals Global Quality Management System (QMS) including Management Review Quality System Metrics and Reporting Regulatory Intelligence Quality System Impact Assessments and Quality System integration activities associated with acquisitions and strategic business initiatives. Partners closely with Quality Regulatory Affairs Operations Manufacturing R&D Supply Chain IT and other functional leaders to ensure QMS remains compliant effective scalable and aligned with evolving regulatory requirements and business objectives. Serves as a key partner to the Director Global Quality Systems helping drive quality system performance governance inspection readiness and continuous improvement across the global organization.

Job Summary:

The Senior Manager Global Quality Systems is responsible for the leadership oversight and continuous improvement of key components of CooperSurgicals Global Quality Management System. This role ensures ongoing compliance with applicable global regulations and standards including FDA QMSR ISO 13485 MDSAP EU MDR and other relevant requirements. Leads activities related to Management Review Quality System metrics and reporting regulatory intelligence standards management quality system impact assessments and merger and acquisition integration efforts. Through effective governance analytics and cross-functional collaboration this role provides visibility into QMS health identifies compliance risks and opportunities and ensures regulatory and standards changes are effectively assessed and incorporated into the Quality Management System.

Essential Functions & Accountabilities:

• Support the governance effectiveness and continuous improvement of the global QMS.
• Drive harmonization compliance and operational excellence across global quality system processes.
• Partner with process owners and cross-functional stakeholders to identify and mitigate quality system risks while ensuring inspection readiness.
• Lead the global Management Review program including planning reporting action tracking and continuous improvement.
• Develop and maintain quality system KPIs dashboards and performance reporting to provide visibility into QMS effectiveness compliance status and emerging risks.
• Prepare executive-level reporting on QMS health quality objectives risks and improvement opportunities.
• Monitor process effectiveness and drive improvements that enhance compliance efficiency and user experience.
• Monitor evolving global regulations standards guidance documents and industry best practices impacting the Quality Management System.
• Lead quality system impact assessments and gap analyses to determine the effect of regulatory and standards changes on existing QMS processes.
• Develop and track implementation plans to ensure timely incorporation of regulatory and standards requirements into the QMS.
• Partner with Regulatory Affairs and Quality leadership to evaluate new or revised regulatory requirements.
• Lead Quality Systems due diligence integration planning and QMS harmonization activities associated with acquisitions and strategic business initiatives.
• Assess quality system maturity identify compliance gaps and implement integration plans that align acquired entities with CooperSurgical processes.
• Support implementation and optimization of electronic Quality Management Systems (eQMS) and related quality system enhancement initiatives.
• Support regulatory inspections audits and remediation activities as required.
• Lead coach and develop a team responsible for Quality Systems governance reporting compliance monitoring and improvement initiatives.

• Establish performance expectations prioritize resources and foster a culture of quality accountability and continuous improvement.

  Travel: This position may require 20% domestic or international travel.

Qualifications

Knowledge Skills and Abilities:

• Strong working knowledge of MasterControl Veeva Trackwise or similar eQMS platforms.
• Solid understanding of 21 CFR 820 ISO 13485 EU MDR MDSAP.
• Demonstrated ability to manage and develop teams.
• Ability to balance operational priorities with compliance requirements.
• Strong organizational analytical and communication skills.
• Ability to collaborate across global crossfunctional groups.

Preferred

• Experience participating in or supporting large-scale enterprise software implementations including data migration and data mapping activities.
• Advanced proficiency in Excel for data analysis and reporting.
• Professional certification such as Certified Quality Auditor (CQA) or similar.

Work Environment:

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

Experience:

• 8 years of experience in quality management systems within a regulated med tech industry.
• 7 years of people leadership and team development.
• Experience managing quality systems with ISO 13485 and FDA 21 CFR Part 820 MDSAP and EU MDR requirements.

Preferred

• Exposure to other adjacent quality system compliance requirements such as 21 CFR Part 210/211.
• Prior involvement in supporting external and internal audits.
• Experience with electronic Quality Management Systems (eQMS) and/or implementation of eQMS such as Veeva Trackwise MasterControl.

Education:

• Bachelors degree in a relevant field such as Engineering Life Sciences Quality or a related discipline.

Preferred

• Professional ASQ certification (CQPA CQA CMQ/OE etc.)
• Project Management Professional certification (PMP)