Global QARACA Program Director
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Global QARACA Program Director
- 2026-39024
- California, United States
- Irvine, California, United States
- Quality and Regulatory
- Hybridarbeit
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.
Total Rewards Package: At Bio-Rad, we’re empowered by our purpose and recognize that our employees are as well. That’s why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle.
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, 401k 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.
Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.
Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it. #LI-AK1 #LI-Hybrid
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