Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performance objectives
Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs
Provide technical, regulatory, and operational leadership to ensure Quality systems comply with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements
Drive harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency
Partner with Operations, R&D, Regulatory Affairs, Global Service Organization, Commercial and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle
Promote a culture of continuous improvement by identifying opportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS)
Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits
Monitor Quality performance using metrics and data analytics to identify risks, drive root cause analysis, and implement sustainable improvements
Coach and mentor emerging Quality leaders and technical experts to build organizational capability and ensure robust succession planning
Communicate Quality and Compliance strategy, progress, and risk mitigation plans to senior leadership and cross-functional stakeholders
Manage departmental budget and resources effectively, identifying opportunities to drive cost efficiencies while maintaining compliance and quality standards
Perform other work-related duties as assigned.
Requirements
Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline required
12+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including at least 3 years in people leadership
Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR
Proven ability to lead and develop high-performing teams and build future technical and people leaders
Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations
Excellent collaboration, influence, and communication skills across functional and organizational boundaries
Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement
Experience leading in a matrixed, global organization and managing competing priorities effectively
Commitment to scientific integrity, compliance excellence, and continuous improvement.