Clinical Functional Excellence Lead

Hoffmann-La Roche • Pleasanton, CA

373d • $96,800 - $179,800

About The Position

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

Requirements

• Bachelor's degree
• 6 years of experience in Clinical Operations environment or in a Quality Function
• 6 years of experience in working in a highly regulated environment
• 3 years' experience in working on projects as well as in project management, including global cross-functional projects.

Nice To Haves

• Master's or PhD (preferably in Life Sciences)
• Knowledge of applicable standards and regulations for clinical trials (ICH/GCP, U.S. CFR, GxP, ISO, IVDR, GDPR)
• Solid know how in the Medical Device / IVD business is a plus
• Ability to act self-motivated with adequate oversight
• Ability to influence multidisciplinary teams and to achieve results, act as change agent
• Basic experience in resolving complex issues in a matrix organization
• Strong analytical and decision making skills in a complex, fast paced, and changing environment
• Ability to work in global teams, cultural awareness
• Ability to interact with and to present to higher hierarchy levels and global audiences
• Competency to design and implement cross-functional processes
• Expertise in project coordination and management
• Advanced Microsoft Office or Google G-suite skills
• Willingness and ability to travel regionally or internationally up to 30% of time.

Responsibilities

• Implementing process improvement activities in line with Roche processes and international regulations.
• Identifying improvement opportunities and amending current processes.
• Providing compliance support and advice on regulations such as Roche Code of Conduct, ICH GCP, IVDR, FDA regulations, and GDPR.
• Collaborating with partners on a global and local level to drive process improvements.
• Contributing to innovative sustainable solutions in support of establishing a standardized approach and oversight of standard processes.
• Developing and supporting training programs and materials.

Benefits

• Discretionary annual bonus based on individual and Company performance.

What This Job Offers

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