Quality Assurance Supplier Lead Auditor
1 month ago
At FUJIFILM Diosynth Biotechnologies, we are seeking a highly skilled Quality Assurance Supplier Lead Auditor to join our Global Supplier Quality Management team. As a key member of our team, you will be responsible for managing and leading the Supplier auditors performing Supplier Audits regionally and internationally, ensuring compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs.
Key Responsibilities:- Lead the Supplier auditor team in performing audits, generating audit reports, and managing supplier CAPA to ensure required actions are completed within the required timeframe.
- Collaborate with site management to instill a 'Quality Culture' by coaching in applying GMP Principles, including the underlying rationale of those principles.
- Support the organization in conducting internal audits and hosting audits/inspections.
- Manage Supplier notification mailbox to ensure active management and delegation within the supplier team and associated Quality Compliance Assessments are delegated appropriately.
- Develop metrics to provide visibility of audits due, planned audit dates, Audits complete, Audit reports process timelines, and overdue audits.
- Develop common finding categories to allow identification of risk areas across the Supplier base.
- Proactive planning to ensure maintenance of audits assigned to the Supplier auditor team, to mitigate overdue.
- Experience working in an auditing role within the Pharmaceutical/Medical Device industry.
- Bachelor's Degree in the Life Sciences/Engineering field with 3 years of relevant QA auditing experience.
- Associate's Degree in Life/Sciences/Engineering field with 5 years of relevant QA auditing experience.
- Experience with Good Documentation Practices, cGMP/GLP regulations.
- ASQ Quality Auditor Certification.
- Knowledge and understanding of the following principles and guidelines: EU EudraLex Volume 4 GMPs, 21 CFR Parts 111/210/211 (FDA), ISO, and related International Regulations affecting pharmaceutical products and medical devices.
- Working knowledge of industry-related guidelines such as ICH Q7, GHTF, and IPEC.
- Leadership/Supervisory experience.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law. If an accommodation to the application process is needed, please email or call.
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