VP, On-Market Quality

Cepheid; Sunnyvale (CA); On-site; USD 238,000 - 327,000; Full time

Job summary

Cepheid is seeking a veteran leader to provide strategic direction for multi-site on-market product quality and regulatory compliance. You will drive post-market surveillance, investigations, and field actions while ensuring robust QMS integration and global process ownership.

The role reports to the SVP, Quality, Regulatory & Clinical Affairs and sits in North America, with offices in Sunnyvale, CA, Newark, or Lodi, and requires extensive cross-functional collaboration across R&D, Regulatory,

Qualifications

• Bachelor's 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.

Responsibilities

• 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.

Skills

Quality leadership

Regulatory compliance

Cross-functional collaboration

Lean Six Sigma

Danaher Business System

Education

Bachelor's degree in engineering, biology, chemistry, or a related field

Job description

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.

Vice President, On-Market Quality

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.

In this role, you will have the opportunity to:

• 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.

The essential requirements of the job include:

• 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.

It would be a plus if you also possess previous experience in:

• 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 decision-making.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

Ability to travel occasionally as needed to support global, multi-site operations.

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether its a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

The annual salary range for this role is $238,000-327,000.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Companys sole discretion, consistent with the law.

Join our winning team today. Together, well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

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