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Regulatory Affairs Lead Auditor
2 months ago
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 an IVD medical device GMP facility, focusing on instruments, software, and reagents within the Clinical Diagnostic Group. Your role will involve managing the quality management system audit program and providing comprehensive reports to senior management. This encompasses a wide range of regulatory inspections, including those from the FDA, notified bodies, and other international GMP audits.
Key Responsibilities:
Plan, prepare, execute, and deliver quality audits in a GMP-regulated environment according to a structured audit schedule. This includes managing audit checklists, generating audit reports, addressing non-conformances, and conducting effectiveness checks. You will also provide management with metrics related to both internal and external audits. Demonstrate excellent written and verbal communication skills in English, effectively engaging with various departments, employees, and management levels. Exhibit strong organizational skills and attention to detail, alongside effective time management and a robust quality-focused mindset. Possess experience in organizing quality audits for regulatory inspections (such as FDA and notified bodies) and provide necessary documentation to support GMP paper audits for international subsidiaries. Interpret ISO standards, FDA guidance, and relevant regulations, implementing new 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 considered advantageous. Work Experience: 5-7 years of auditing experience in a regulated ISO or FDA manufacturing environment or equivalent experience. Proficient in MS Office applications (including Excel, Word, PowerPoint, Visio) and Adobe Acrobat Pro, with the ability to provide quality metrics for executive review. A quality-centric approach to ensure the operational integrity of the quality management system in compliance with regulations. Proven capability to lead an audit team across functions, as well as the ability to work independently without direct supervision.Work Environment: This position offers a hybrid work model, allowing for a combination of in-office and remote work.
Total Rewards: Bio-Rad is committed to providing a competitive and comprehensive Total Rewards Program that values inclusivity and meets the diverse needs of our workforce. Our offerings are designed to enhance the overall health, wealth, and well-being of our employees and their families throughout various stages of their careers.
Benefits: We offer a range of benefits, including competitive medical plans, free HSA funds, fertility assistance, group life and disability insurance, paid parental leave, a 401k plan with profit sharing, an employee stock purchase program, mental health resources, extensive learning and development opportunities, education benefits, and pet insurance.
Compensation: The estimated salary range for this role is competitive and will be discussed during the offer process, taking into account various factors such as geographic location, experience, and skills.
Company Overview: Bio-Rad has been a leader in advancing the discovery process and transforming science and healthcare for over 70 years. As one of the top five life science companies globally, we are dedicated to developing, manufacturing, and marketing a wide array of high-quality research and clinical diagnostic products that contribute to healthier lives worldwide.
EEO 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.
