Regulatory Affairs Lead Auditor

1 week ago

Hercules, California, United States Bio-Rad Full time

As a key member of the Regulatory Affairs and Quality Assurance team, you will oversee the coordination of both internal and external audit programs for a Good Manufacturing Practice (GMP) facility specializing in in vitro diagnostic (IVD) medical devices, including instruments, software, and reagents within the Clinical Diagnostic Group. Your role will encompass managing the quality management system audit program and providing comprehensive reports to upper management. This includes a wide array of regulatory inspections such as those conducted by the FDA, notified bodies, and other international GMP audits.

Key Responsibilities:

Organize, prepare, execute, and present quality audits in compliance with a predetermined audit schedule within a GMP environment. This involves managing audit checklists, generating audit reports, addressing non-conformances, and conducting effectiveness checks. You will also supply management with metrics related to both internal and external audits. Demonstrate exceptional written and verbal communication skills in English, facilitating interactions across various departments and levels of management. Exhibit strong organizational skills and attention to detail, alongside effective time management abilities and a robust quality-focused mindset. Possess experience in coordinating quality audits for regulatory inspections (including FDA and notified bodies) and providing necessary documentation to support GMP paper audits for international subsidiaries. Show proficiency in interpreting ISO standards, FDA guidelines, and regulations, implementing new regulatory requirements within the quality management system as necessary.

Qualifications:

Education: A Bachelor’s degree or higher in Biology or Bioengineering, with a focus on regulatory science being advantageous. Work Experience: 5-7 years of auditing experience in a regulated ISO or FDA manufacturing environment or equivalent experience. Proficient in Microsoft Office applications (such as Excel, Word, PowerPoint, Visio) and Adobe Acrobat Pro, with the capability to provide quality metrics for executive management review. A quality-centric approach to ensure the operational integrity of the quality management system in accordance with regulations. Proven ability to lead cross-functional audit teams while also working independently without direct supervision.

Work Environment: This position offers a hybrid work arrangement, allowing for a combination of in-office and remote work.

Compensation and Benefits: Bio-Rad provides a competitive and comprehensive Total Rewards Program that addresses the diverse needs of our workforce. Our benefits include a variety of medical plans, HSA contributions, fertility assistance, life and disability insurance, paid parental leave, a 401k plan with profit sharing, an employee stock purchase program, mental health resources, and extensive learning and development opportunities.

Company Overview: For over 70 years, Bio-Rad has been dedicated to advancing the discovery process and transforming the fields of science and healthcare. As a leading life science company, we develop, manufacture, and market a wide range of high-quality research and clinical diagnostic products, contributing to healthier lives globally. Our collaborative culture and supportive leadership foster an environment where employees can thrive and make a meaningful impact.

Equal Opportunity Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, welcoming candidates from all backgrounds. We encourage applications from veterans, individuals with disabilities, and people of all races, colors, genders, sexual orientations, gender identities, religions, national origins, and citizenship statuses.

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