VP, Manufacturing Quality

Job content

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 Vice President, Manufacturing Quality will provide leadership, overall strategic direction and operational coordination of activities for a multi-site Manufacturing Quality Operations team. This leader will serve as the management representative for the site operations and ensure compliance with FDA QSR, ISO 13485:2016, and other applicable global regulatory requirements in alignment with company objectives and Quality standards. They will employ to utilization of Danaher Business Systems to drive safety, quality, delivery and productivity to products manufactured at all sites under a harmonized Quality Management System.

The Vice President, Manufacturing Quality will report directly to the Vice President, Global Quality and will supervise all operational sites in EMEAI including Solna, Bangalore and Chennai Quality organization encompassing the Quality Control, Quality Engineering, Quality Assurance and Quality Systems functions.

This position is part of the Global Quality team. At Cepheid, our mission is Delivering a Better Way to improve patient outcomes by enabling access to molecular diagnostic testing everywhere.

In this role, you will have the opportunity to:

• Build, develop and manage a high performing Operations Quality team that includes Quality Control, Quality Engineering, Quality Assurance and site Quality Systems teams.
• Develops resourcing strategies, allocates budgets, staff, tools and specialized support necessary for efficient operations. Ensure there are no significant interruptions to the business due to quality or compliance issues.
• Build interface with Research and Development, Clinical Affairs, Regulatory Affairs, Manufacturing Operations and Commercial Operations to assure that product meets pre-launch, production and post launch requirements.
• Lead site Change Management and Risk Management activities
• Communicates and reports regularly to Quality management, users and staff on the status of the quality system.
• Utilize Danaher Business System (DBS) tools to drive compliance and effective processes
  

The essential requirements of the job include:

• Bachelor’s Degree in engineering, biology, chemistry, or related field with 20+ years of experience; OR Master’s degree with 18+ years of experience.
• Minimum 15 years of experience in In Vitro Diagnostics, quality engineering and /or quality systems in FDA regulated industry. Minimum 6 years of department lead experience in managing both processes, resources, and people.
• Medical Device industry experience, preferably IVD
• Expert knowledge of US FDA and ISO requirements
• The ability to develop strategic goals and objectives from knowledge base and understanding of a customer’s business. Manage changing conditions, processes and approaches; lead organizations through change effectively.
• Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.
• Track record of measurable, operational improvements to Quality Systems related functions.
• DBS, LEAN or Six Sigma operational excellence training or certification
  

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

• Training and/or certificates in quality or regulatory affairs (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)
• Experience in Manufacturing Operations with managing large teams of Direct/Indirect labor
• Understanding of P&L management with strong financial and analytical skills.
• Master or Ph.D. degree preferred with experience in Molecular Diagnostics
  

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 danaherbenefitsinfo.com.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

If you’ve ever wondered what’s within you, there’s no better time to find out.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

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.

If you’ve ever wondered what’s within you, there’s no better time to find out.