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Quality Assurance Lead Auditor
2 months ago
We are seeking a highly skilled Quality Assurance Lead Auditor to join our Global Supplier Quality Management team at FUJIFILM Diosynth Biotechnologies. As a key member of our team, you will be responsible for managing and leading Supplier auditors in performing audits regionally and internationally, ensuring supplier integrity and oversight.
Key Responsibilities- Lead the Supplier Auditor Team in conducting audits, generating audit reports, and managing supplier CAPA to ensure timely completion of required actions.
- Collaborate with site management to instill a 'Quality Culture' by coaching in applying GMP Principles and underlying rationales.
- Support internal audits and hosting audits/inspections, ensuring compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs.
- Manage the Supplier notification mailbox, ensuring active management and delegation within the supplier team and associated Quality Compliance Assessments.
- Develop metrics to provide visibility of audits due, planned audit dates, audits complete, audit reports process timelines, and overdue audits.
- Identify risk areas across the Supplier base by collating and communicating common finding categories.
- Proactively plan to ensure maintenance of audits assigned to the Supplier auditor team, mitigating overdue audits.
- Bachelor's Degree in the Life Sciences/Engineering field and 3 years auditing experience within the Pharmaceutical/Medical Device industry.
- Experience with Good Documentation Practices, cGMP/GLP regulations.
- ASQ Quality Auditor Certification and knowledge of EU EudraLex Volume 4 GMPs, 21 CFR Parts 111/210/211 (FDA), ISO, and related International Regulations affecting pharmaceutical products and medical devices.
- Leadership experience and working knowledge of industry-related guidelines such as ICH Q7, GHTF, and IPEC.
We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large. We are an equal opportunity and affirmative action employer, committed to diversity and inclusion in the workplace.
