Director, Global QARACA Programs

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

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.

How You’ll Make An Impact

• 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.

What You Bring

• Education: Bachelor’s degree in a relevant technical discipline or equivalent experience required; advanced degree or MBA preferred.
• Work Experience: 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. Veeva experience is preferred.
• Project Management Professional (PMP) certification preferred.

Location: This position must be based in Hercules, CA or Irvine, CA and requires the employee to be located within commuting distance of the office.

Benefits: We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401(k) plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG’s), and more!

Compensation: The estimated base salary range for this position is $204,800 to $281,600 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high‑quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio‑Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.