Quality Assurance Lead Auditor
2 weeks ago
FUJIFILM Diosynth Biotechnologies is seeking a highly skilled Quality Assurance Lead Auditor to join our Global Supplier Quality Management team. As a key member of our team, you will be responsible for leading and managing supplier audits, ensuring compliance with quality policies and site SOPs.
Key Responsibilities- Leadership: Provide coaching and guidance to site management on implementing a 'Quality Culture' and applying GMP principles.
- Supplier Audits: Lead the FDBT Supplier Auditor Team in performing audits, generating audit reports, and managing supplier CAPA to ensure timely completion.
- Compliance Delivery: Support the organization in conducting internal audits and hosting audits/inspections.
- Supplier Management: Manage the supplier notification mailbox, ensuring active management and delegation within the supplier team and associated Quality Compliance Assessments.
- Metrics and Reporting: Develop metrics to provide visibility of audits due, planned audit dates, audits complete, audit reports process timelines, and overdue audits.
- Collation and Communication: Develop common finding categories to identify risk areas across the supplier base.
- Proactive Planning: Ensure maintenance of audits assigned to the Supplier auditor team to mitigate overdue audits.
- New Business Growth: Work with Quality management to ensure quality systems support cGMP manufacturing of pre-clinical to commercial products.
- Cross-Functional Collaboration: Collaborate, align, and foster cross-functional business relationships within Global functional groups to ensure risks are identified, mitigated, and communicated.
- Regulatory Compliance: Adhere to Fujifilm Diosynth procedures and regulatory requirements for supplier quality management.
- Supplier Quality Management: Support supplier quality management activities to ensure continued compliance.
- Audit Preparations and Follow-ups: Support supplier audit preparations and post-audit follow-ups, process supplier complaints and change notifications, and assist client audit requests with site documentation preparation and/or gathering.
- Training and Site Actions: Ensure no overdue training or site actions and support other QA teams and functions in completing site actions.
- Global Supplier Assurance: Participate and represent the Texas Site in supporting joint audits and continuous improvement projects.
- Education: Bachelor's Degree in the Life Sciences/Engineering field.
- Experience: 3 years auditing experience within the Pharmaceutical/Medical Device industry.
- Skills and Abilities: Excellent written and oral communication skills, excellent organizational, analytical, data review, and report writing skills, ability to set personal performance goals and provide input to departmental objectives, ability to multitask and easily prioritize work.
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