Senior Manager, Quality Systems

Job Description 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 which makes everything possible. The Senior Manager, Quality Systems is responsible evaluating and improving the Quality Management System by employing best practices to ensure compliance to applicable Medical Device and IVD regulations/standards and Danaher Policies. This role has the opportunity to work with other Cepheid sites around the world to build a world-class Global Quality Management System. This position is part of the Quality department and will be located in Bengaluru, India. The Quality department collaborates with cross-functional business partners to ensure that customer needs and safety are met, government regulations and quality requirements are effectively monitored, measured, maintained and continuously improved. In this role, you will have the opportunity to: - Manage the Indian Development Center (IDC) Internal Audit program to schedule, execute, and document audits in compliance with Cepheid Policy and procedures, ensuring timely closure of findings with corrective actions - Manage external regulatory audits by organizing pre-audit logistics, hosting audits, and directing post-audit corrective action implementation - Implement and maintain global document control processes aligned with FDA Quality System Regulation (QSR), ISO 13485, and other applicable regulatory standards - Administer and maintain the Quality System Training application, Compliance Wire, ensuring accurate configuration, user access, and training completion tracking - Monitor and ensure compliance with FDA regulations, European Union In Vitro Diagnostic Regulation (IVDR), and other global regulatory requirements applicable to medical devices and diagnostics - Maintain audit records, document control logs, and training system data to provide measurable compliance evidence during inspections and regulatory reviews - Coordinate cross-functional regulatory readiness activities to ensure systems, documentation, and training platforms meet audit and inspection requirements The essential requirements of the job include: - Bachelor's degree in a scientific or engineering discipline with 9+ years of industry experience OR Master's degree with 7+ years of industry experience - Minimum 2 years of leadership experience in regulated medical device, diagnostics, or life sciences environments - Proficiency with FDA Quality System Regulation (QSR), ISO 13485, and EU IVDR compliance frameworks - Demonstrated experience implementing and maintaining domestic and international quality management systems - Direct involvement with regulatory audits, inspections, and certification processes in FDA- and ISO-regulated industries - Hands-on experience with electronic quality management systems (eQMS) or document control platforms used in regulated environments - Ability to travel up to 10% for audits, inspections, or operational support It would be a plus if you also possess: - Certified Quality Auditor (CQA) or ISO 13485 Lead Assessor certification Cepheid, a Danaher 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. Check out our benefits at . Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's 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 .