VP, -Market Quality

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cepheid, one of Danahers 15+ operating companies, our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement, you help turn ideas into impact innovating at the speed of life.

At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, youll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the worlds most complex health challenges. Together, we bring MORE change to the world.

Learn about the Danaher Business System which makes everything possible.

is responsible for providing strategic leadership and operational oversight for multi-site on-market product performance, sustainment, and maintenance activities within Quality and Regulatory Affairs. In addition to helping sustain a robust Quality Management System, this leader drives global process ownership across on-market quality and regulatory compliance including post market surveillance activities supporting complaint management, adverse event reporting and field action management, technical change management, and labeling content management to support compliant and uninterrupted product availability.

This position reports to the Senior Vice President, Quality, Regulatory & Clinical Affairs and is part of the Quality and Regulatory Affairs organization located in North America. This role will sit in one of our offices in Sunnyvale, Newark, or Lodi, CA and will serve in a global capacity.

• Lead the global strategy and execution for on-market product performance, sustainment, and Quality Management System maintenance activities across multiple sites.

• Oversee global process ownership for complaint handling, investigations, field actions, recalls, adverse event reporting, and defect tracking to ensure effective integration within the Quality Management System.

• Direct on-market product change management, risk management, market expansion support, and CE mark sustainment under IVDR.

• Engage and influence across Research and Development, Clinical Affairs, Regulatory Affairs, Medical and Scientific Affairs, Manufacturing, and Commercial teams to ensure products meet on-market requirements and remain compliant in the field.

• Drive compliant, efficient global labeling and MAPSS-related activities in support of business and regulatory objectives.

• Use Danaher Business System tools to improve quality, delivery, productivity, and business continuity while minimizing quality or compliance-related disruptions.

• Build and develop a high-performing organization through resource planning, budgeting, communication, and employee development aligned to strategic and quality goals.

• Bachelors degree in engineering, biology, chemistry, or a related field.

• 20+ years of experience in in vitro diagnostics, quality engineering, and/or quality systems within an FDA-regulated industry.

• 10+ years of experience leading functions, processes, and teams in a complex, global environment.

• Deep knowledge of FDA Quality System Regulation, ISO 13485, and global regulatory requirements applicable to medical devices or IVD.

• Experience leading complaint handling, investigations, field actions, recalls, risk management, and technical change management within a harmonized Quality Management System.

• Demonstrated ability to drive measurable operational improvements using Danaher Business System, Lean, Six Sigma, or similar operational excellence methods.

• Experience collaborating across executive leadership and cross-functional global teams to support compliant on-market product sustainment.

• Advanced degree in a relevant scientific, engineering, or technical discipline.

• Professional certifications or formal training in quality, regulatory affairs, Lean, or Six Sigma. (e.g., CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)

• Experience in molecular diagnostics, large-scale team leadership, and P&L-informed…