Senior Manager, Clinical Quality and Compliance

Cepheid • Austin, TX

164d • $140,600 - $200,300

About The Position

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.

Requirements

• Bachelor’s degree in science with 14+ years of clinical quality/GCP experience within the device industry OR Master’s degree in science with 12+ years of clinical quality/GCP experience within the device industry.
• Knowledge of US requirements and regulations related to Good Clinical Practice with hands on experience in dealing directly with FDA and other regulatory agencies.
• Proven track record of managing successful clinical audits and define/support non-conformances and CAPA.
• Ability to build strong relationships and trust with global internal and external stakeholders.
• 4+ years managing people.

Nice To Haves

• Understanding of IVD regulations for other geographies (e.g., Asia, Africa, and Latin America).
• FDA audit (e.g., BIMO) process.

Responsibilities

• Refine, expand and oversee the design, build and execution of a robust and global clinical affairs compliance strategy and program including internal GCP auditing.
• Provide leadership to managers and professional associates and is accountable for the performance and results of multiple related teams.
• Apply thorough knowledge of current international requirements of GCP, GLP, FDA, ICH, EU, and applicable global regulations.
• Ensure Clinical Affairs compliance with review process for manuscripts and other scientific communications generated by the Clinical Affairs department.
• Evaluate systems used to support Clinical Affairs activities and ensure compliance with applicable international and national standards, regulations, and guidelines.
• Influence managers and leaders on subjects related to compliance, while working collaboratively with a wide range of new product development and post-market surveillance stakeholder groups.

Benefits

• Comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
• Bonus/incentive pay.
• Flexible, remote working arrangements for eligible roles.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees