Clinical Functional Excellence Lead

Hoffmann-La Roche • Tucson, AZ

366d • $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. This position focuses on process improvement, regulatory compliance, training, and inspection readiness activities across Clinical Operations. You will work with global and regional teams to ensure consistency and compliance with Roche guidelines and international regulations, while aiming to improve both efficiency and quality of the project outcomes.

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)
• 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
• Comprehensive health insurance
• 401k plan with company matching
• Paid time off and holidays
• Employee assistance programs
• Professional development opportunities

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