Global QARACA Programs & Quality Transformation Leader

Tri-Valley Career Center; Pleasanton (CA); On-site; USD 204,800 - 281,600; Full time

Benefits offered by this job

Medical plans

Free HSA funds

Fertility stipend

Group life and disability

Paid parental leave

401(k) + profit sharing

Employee stock purchase program

Mental health platform

Learning & development

Education benefits

Student debt relief

Pet insurance

Wellness challenges

Paid time off

ERGs

Job summary

Bio-Rad is seeking a Global QARACA Program Director to lead a cross-functional team responsible for enterprise-wide quality and regulatory transformation initiatives, including global eQMS and RIM implementations. You will drive strategic planning, governance, budgets, and execution with internal stakeholders.

The role requires 15+ years in regulated industries, strong leadership, and experience with AI-enabled regulatory processes.

Qualifications

• Bachelor’s degree in a relevant technical discipline or equivalent experience.
• 15+ years leading complex cross-functional programs in regulated industries (biotech/medical devices).
• Experience with device requirements, QMS harmonization, and regulated frameworks (FDA/EU/MDSAP).
• Strong leadership, communication, and stakeholder management with change management.
• Proficiency with AI tools and data literacy; apply AI-enabled solutions within regulated processes.
• Enterprise-level quality/regulatory systems implementation; Veeva experience preferred; PMP certification preferred.

Responsibilities

• Define and lead Global QARACA automation and digital operations strategy, aligning with priorities and regulatory expectations.
• Lead strategic planning, program governance, and executive reporting.
• Partner with cross-functional leaders to align priorities and execute initiatives.
• Govern programs, ensure milestones, and enable informed decision-making.
• Drive delivery of a broad portfolio with timelines, budgets, and quality standards.
• Manage dependencies, risks, and issue resolution for successful delivery.
• Lead teams to deliver scope and budgets; develop leadership succession.
• Oversee SharePoint governance and support priority tracking and town halls.

Skills

Leadership

Stakeholder management

AI tools

Data literacy

Veeva

Education

Bachelor’s degree in a relevant technical discipline

MBA or advanced degree preferred

Tools

PMP certification

Job description

Bio-Rad is seeking a Global QARACA Program Director to lead a cross-functional team responsible for enterprise-wide quality and regulatory transformation initiatives, including global eQMS and RIM implementations. You will drive strategic planning, governance, budgets, and execution with internal stakeholders.

The role requires 15+ years in regulated industries, strong leadership, and experience with AI-enabled regulatory processes.