Director, Quality Management Systems

Position Summary

This position reports to the Sr Director, Quality Excellence & Systems. Improve and maintain the global Quality System in line with ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (EU-MDR), MDSAP International Regulations (Australia, Brazil, Canada, Japan, USA) and regulatory requirements applicable to the Quality Management System (QMS). The role will also involve multi-site collaboration with various facilities and departments. Provide regular status reports to management as required.

As a People Manager, you play a pivotal role in leading, developing, and inspiring a high-performing team to deliver exceptional results aligned with organizational goals. You are responsible for building organizational capability through effective talent development, fostering a culture of accountability, and promoting continuous improvement. Your role requires strong cross-functional collaboration to ensure alignment and drive integrated solutions across the business. As a leader, you are a visible champion of our culture and values, creating an inclusive, purpose-driven environment where individuals feel empowered to contribute and grow.

Principal Responsibilities

•    Plan and manage the duplication and certification of the QMS during the divestiture
•    Own and liaise with eQMS vendor, systems team, and global process owners to manage divestiture and subsequent system integrations (e.g., PLM, ERP) as needed 
•    Direct facilities (Athlone, Morrisville, Pleasanton, Santa Barbara, and others as assigned) and their Quality Management Representatives and ensure the QMS is consistently established, implemented, and maintained
•    Partner with Regulatory Affairs and communicate with Notified Bodies and regulators with respect to certificates, audits, and QMS elements as necessary
•    Support quality system and regulatory audits including by not limited to FDA, Notified Body ISO 13485/MDSAP/EU MDR, Customer and Internal audits
•    Develop, implement and monitor key metrics used to assess Quality System Execution 
•    Support change control activities including reviewing and approving QMS documentation, supporting impact assessment, and attending technical reviews to provide feedback on QMS processes
•    Develop, enact, and maintain the global QMS certificate strategy for the enterprise
•    Ensure alignment between the Global QMS and facilities local QMS
•    Ensure consistency between the design center QMS and activities
•    Lead Strategic QA Projects
•    Establish function specific quality objectives, create quality planning documentation when necessary and lead a continuous monitoring process for the facilities based on inputs from relevant stakeholders
•    Manage budgetary requirements and ensure compliance of expenditures to meet budget
•    Build interdependent relationships with R&D, Marketing, Operations and RA and Administration
•    Support the Global Corrective Action and Preventive Action (CAPA) program by reviewing and approving Global Quality Management System CAPAs and participating in the executive CAPA Review Board (eCRB) as the Quality Management Systems representative 
•    Participate in mergers and acquisitions providing due diligence and Quality support
•    Support and lead additional activities as assigned by Sr. Director, Quality Excellence & Systems or Executive Leadership

Education / Experience Requirements

•    Bachelor of Science (preferred in Engineering, Microbiology or other technical degree) 
•    Experience Managing the Quality Management Systems and medical device regulations
•    Experience with regulatory inspections/audits
•    Experience with Project Management 
•    Experience and knowledge of process risk management and CAPA systems
•    Excellent organizational skills
•    Excellent written and verbal communication skills
•    Excellent stakeholder management skills

Specialized Skills / Other Requirements

•    Certified Quality Manager preferred
•    PMP certification preferred
•    Experience with Veeva preferred 

TRAVEL REQUIRED: 10%

WORKING ENVIRONMENT:
☒ Office/Professional        ☐ Plant/Manufacturing    ☐ Remote/Field     ☐ Laboratory 

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