As a Quality Programs Manager 4, you will be a key leader responsible for ensuring regulatory compliance, driving continuous improvement, and embedding industry best practices across our Quality Management System (QMS). You will lead and manage cross-functional quality and compliance initiatives, working collaboratively with stakeholders across Quality, Regulatory Affairs, R&D, Operations, Manufacturing, Engineering, Supply Chain, Procurement, Marketing, and Corporate Quality to achieve organizational objectives.
In this pivotal role, you will harmonize quality processes across sites and business units, define clear program objectives and metrics, and proactively manage risks. You will own quality planning documentation, champion process analysis and optimization, and play a central role in regulatory inspection readiness and response. Your leadership will foster transparent communication, program success, and a culture of excellence.
Knowledge
- In-depth understanding of FDA Quality Management System Regulations (QMSR), ISO 13485, ISO 14971, and related medical device and IVD regulatory requirements.
- Proficiency in quality improvement tools and methodologies, including CAPA, Health Hazard Analysis (HHA), HRA, Health Hazard Evaluation (HHE), MRB, and SCAR.
- Direct experience implementing and managing Quality Management Systems in the medical device or in-vitro diagnostic industry.
- Advanced knowledge of project and program management methodologies, frameworks, and best practices.
- Familiarity with digital quality solutions such as eQMS, analytics platforms, and project management software.
Skills
- Proven ability to lead, harmonize, and execute complex cross-functional quality and compliance programs across multiple divisions, sites, and regions.
- Strong analytical and critical thinking skills to evaluate risks, issues, and trade-offs with the ability to make sound recommendations.
- Advanced project management skills, including defining scope, scheduling, resource planning, and maintaining program metrics and KPIs.
- Proficient in preparing and presenting data-driven insights, dashboards, and executive summaries to leadership.
- Exceptional organizational skills and attention to detail with the ability to manage multiple priorities and projects.
- Expertise in stakeholder engagement, communications, and facilitating effective meetings (e.g., kickoffs, risk reviews, pre-inspection meetings).
- Experience developing and delivering training on advanced quality and regulatory topics.
Behaviors
- Collaborative leader who builds strong partnerships across business units and functions.
- Proactive and strategic, anticipating risks and implementing effective mitigation strategies.
- Change agent who drives adoption of harmonized processes and a culture of continuous improvement.
- Transparent and effective communicator able to engage stakeholders at all levels with clarity and credibility.
- Committed to ongoing professional development and knowledge transfer.
- Data-driven and focused on achieving measurable results and compliance excellence.
Experience
- Bachelors degree in a technical or related field (Science, Engineering, or similar) required.
- PMP certification or equivalent formal project/program management credential required.
- 10 years of experience in Quality, Compliance, or related functions, preferably within the in-vitro diagnostic or medical device industry.
- Demonstrated track record of leading complex cross-functional quality and compliance programs.
- Experience supporting and driving PMO and Quality improvement initiatives, including defining and refining standards, processes, and tools.
- Proven ability to mentor and develop quality and project management professionals.
- Participation in third-party QMS inspections and audit response activities.