Director, Quality Systems

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about the Danaher Business System which makes everything possible.

The Director, Quality Systems is responsible for providing management and overall strategic direction and operational coordination of activities for site Quality Operations and Regulatory Compliance and ensuring compliance with FDA QSR, ISO 13485:2016, and other applicable global regulatory requirements and alignment with company objectives and Quality Standards.

This position will report directly to the Vice President, Manufacturing Quality and will manage the Newark, CA and Sunnyvale, CA Manufacturing Quality organization encompassing Quality Control, Quality Engineering, Quality Assurance, Quality Systems and Calibration functions. This position will also oversee Quality related matters at the Fremont Distribution Centre (EBLC).

This position is part of the Manufacturing Quality Organization and will be in Sunnyvale, CA. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

• Develop and manage a high performing Quality team including Quality Control, Quality Engineering, Quality Assurance, Quality Systems and Calibration functions.
• Direct and oversee the quality planning processes; and develop resourcing strategies, allocate budgets, staff, tools, and specialized support necessary for efficient operations.
• Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment.
• Maintain the CAPA and NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities.
• Collaborate across the organization at all levels, across functional groups and geographic locations, including executive management; manage matrices effectively.
• Utilize Danaher Business System (DBS) tools to drive compliance and effective processes
• Lead employee development, communication, and training programs in connection with the company's strategic goals, quality objectives, and operational systems.

The essential requirements of the job include:

• Bachelor's Degree in Engineering, Biology, Biochemistry, or related field with 14 years of related experience OR Master’s degree in field with 12+ years of related work experience
• 3 plus years hands-on experience in Biotechnology and Quality Control, or Molecular Biology/PCR assays.
• 4 years of Supervisory or Department Lead experience in managing both processes and resources
• Medical Device industry experience, preferably IVD with expert knowledge of US FDA and ISO requirements for Quality Systems
• Strong team player with excellent interpersonal and communication skills, and experience working with end-users in a mentoring capacity.
• Detail-oriented with strong organizational skills and high-quality standards; able to manage and lead the organization effectively through changing conditions, processes, approaches and audits.
• Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals, with a track record of measurable, operational improvements to Quality Systems related functions.

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

• Seven years of Department Leadership experience in managing both processes and resources; preferably in Molecular Diagnostics.
• DBS, LEAN or Six Sigma operational excellence training or certification.
• Experience in Manufacturing Operations, managing both Direct and Indirect labor.

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Ch