Manager, Commercial Quality - LATAM

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 Manager, Commercial Quality - LATAM is responsible for deploy and implement strategic and tactical plans to ensure compliance with applicable Quality System and country specific regulatory compliance requirements in relation to business objectives and initiatives within LATAM countries.

This position is part of the Quality Team and will be located On Site, at Brazil’s office located in São Paulo. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

• Responsible for establishing and maintaining Quality Management Systems (QMS) in accordance with CEP and relevant regulatory requirements (but not limited to ISO 13485, ISO 9001, ISO 14971, In-Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), FDA (Quality System Regulation) 21 CFR Part 820, 21 CFR Part 11, Medical Device Single Audit Program (MDSAP) as applicable.
• Acts as the site Quality Management Representative for the Cepheid sites within the region as applicable and ensures the achievement and maintenance of site certifications / registrations for the Cepheid sites within the region as applicable. Ensure definition of sites annual quality plans and specific quality goals. Plan and conduct Quality System Management reviews for the Cepheid sites within the region as applicable.
• Ensures that all aspects of Quality and Regulatory Compliance applying to CPs,3PLs and ASPs are satisfactory (e.g. traceability, storage conditions, in country specific regulatory requirements) and documented (e.g. quality or distribution agreements). Supports Commercial and Customer Care teams in the execution of the Channel Partners (CPs) and Authorized Service Providers (ASPs) Third Party Logistics (3PLs) selection and performance monitoring processes, including compliance audits and visits as needed.
• Provides quality and regulatory compliance support to market expansion projects. Ensure the quality and regulatory compliance activities are covered and deliverables are supplied to the project (quality agreements defined, validation performed, etc.). Identify the local and country specific regulatory requirements. Communicates and promotes the importance and value of Quality to all stakeholders, including senior management, associates, customers, suppliers, and regulators.
• Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management, lead matrices effectively. 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.

The essential requirements of the job include:

• Bachelor’s or Master’s degree with previous experience in maintaining and continuously improving Quality Management Systems compliant with but not limited to ISO 13485, ISO 14971, FDA QSR 21 CFR 820, In-Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), Medical Device Single Audit Program (MDSAP).
• Experience with operating in an international multi-site company and matrix organization structure, leading changing conditions, processes, and approaches.
• Fluent Portuguese and English required. Spanish desired.

Travel & Motor Vehicle Record Requirements:

• May have national and international travels
• Valid driver’s license

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.

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 www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.