Sr Quality Manager, Bengaluru

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At Cepheid, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's 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, you'll 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 world's most complex health challenges. Together, we bring MORE change to the world.

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Job Title: Senior Manager - Quality

Job Location: India - Bengaluru

POSITION SUMMARY:

We are currently seeking a Senior Manager -Qualitywho will be responsible initiate and support quality systems activities in all Quality aspects of Cepheid business in India. Be Quality Representative for Cepheid outfacing government regulators during inspection and post market activity.

In this role, you will be responsible for:

• Lead and maintain Cepheid India's Quality Management System (QMS) in alignment with corporate Quality Policy, serving as the Quality Management Representative and ensuring documentation, audits, and training are consistently up to date.
• Develop and implement a tailored Quality Plan and roadmap for the manufacturing site in India, ensuring continuous improvement and compliance.
• Oversee regulatory compliance activities, including adverse event reporting, field actions, product corrective actions, and post-market surveillance in coordination with Indian regulatory authorities.
• Manage external audits and inspections, ensuring readiness and full compliance with applicable standards and regulations.
• Ensure systematic product release through QA batch review, applying appropriate quality controls to work-in-progress and final products to meet internal and regulatory specifications.
• Drive quality performance monitoring, including tracking, trending, and reporting compliance metrics, conducting management reviews, and escalating risks or issues to Executive Management as needed.
• Foster a culture of quality and capability development, ensuring staff are trained, quality objectives are established, and CAPA processes are effectively implemented for continuous improvement.

The required qualifications for the job include:

Education or Experience (in years):

• Bachelor's or master's degree of medical engineering, chemistry, biology and pharmaceutical or above is preferred.
• More than five years experience in similar leadership position in Quality with experience In Vitro Diagnostics or medical device companies or pharmaceutical experiences are preferred
• Having practical experience in ISO 9001/13485, and/or other regulatory system experience in quality auditing is a must.

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

• Lead and maintained Quality Management System (QMS)
• Develop and implement a tailored Quality Plan and roadmap
• Foster a culture of quality and capability development in the past experience

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.

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