Director, Global QARACA Programs

Bio-Rad Laboratories•Irvine, CA

1d•Onsite

About The Position

At Bio-Rad, we are looking for a Global QARACA Program Director to lead a team responsible for enterprise-wide quality and regulatory transformation initiatives, including the implementation of a global eQMS and regulatory information management (RIM) system. The role is accountable for strategic planning, program governance, schedules, budgets, and cross-functional execution, driving programs from initiation through delivery in partnership with internal stakeholders.

Requirements

Bachelor’s degree in a relevant technical discipline or equivalent experience required
15+ years of experience leading complex cross-functional programs in biotechnology, medical devices, or another regulated industry.
Demonstrated experience with device requirements, QMS harmonization, and regulated frameworks (e.g. FDA, EU, MDSAP).
Strong leadership, communication, and stakeholder management skills, with the ability to lead through change and translate strategy into execution.
Proficiency with AI tools and strong data literacy, including the ability to apply AI-enabled solutions within regulated business processes.
Experience leading enterprise level quality and regulatory systems implementation.

Nice To Haves

Advanced degree or MBA preferred.
Veeva experience is preferred.
Project Management Professional (PMP) certification preferred.

Responsibilities

Define and lead Global QARACA automation and digital operations strategy, aligning initiatives with enterprise priorities, regulatory expectations, and operational needs.
Lead strategic planning, program management, operating processes, and executive reporting.
Partner with cross-functional leaders to align priorities and execute strategic initiatives.
Lead program governance and reviews to ensure stakeholder alignment, milestone achievement, and effective decision-making.
Drive execution of a complex portfolio of programs, ensuring alignment with business priorities, timelines, quality standards, and financial objectives.
Manage dependencies, resources, risks, and issue resolution to support successful program delivery.
Lead direct reports and project teams to deliver against scope, timelines, and budgets.
Oversee Global QARACA SharePoint content and governance, and support operating mechanisms such as town halls, team meetings, and tracking of priorities and objectives.
Coach and develop teams, strengthen leadership succession, and build organizational capability while fostering collaboration and accountability.