Supplier Quality Assurance Lead Auditor

2 weeks ago

College Station, Texas, United States FUJIFILM Holdings America Corporation Full time
Position Overview

At FUJIFILM Holdings America Corporation, we recognize the significance of our work and are eager to welcome skilled professionals to our team. As we expand our operations and enhance our capabilities, we seek dedicated individuals who are passionate about making a meaningful impact in the biopharmaceutical industry. Join us in our mission to develop groundbreaking vaccines, therapies, and treatments in collaboration with leading biopharma organizations worldwide. We take pride in fostering a vibrant workplace culture that inspires enthusiasm, energy, and commitment - a concept we refer to as Genki.

Location Insights: While our operational base may be situated in a smaller community, it boasts a rich cultural environment and a variety of local amenities, making it an ideal setting for both families and individuals who appreciate the charm of a close-knit town while remaining connected to larger urban centers. Our facility is strategically located within a dynamic innovation hub, serving as a point of pride for the region.

Role Summary: As a key member of the Global Supplier Quality Management team, the Supplier Quality Assurance Lead Auditor will oversee and direct the activities of Supplier Auditors conducting audits both regionally and internationally, adhering to their designated schedules to ensure supplier integrity and compliance. This role encompasses all aspects of supplier quality management and auditing in alignment with FUJIFILM's quality standards and operational procedures.

Key Responsibilities:

  • Leadership: Collaborate with site leadership to promote a culture of quality by mentoring staff in the application of Good Manufacturing Practices (GMP) and their foundational principles.
  • Audit Management: Lead the Supplier Auditor Team in executing audits, generating comprehensive audit reports, and managing supplier Corrective and Preventive Actions (CAPA) to ensure timely resolution.
  • Compliance Oversight: Assist in conducting internal audits and facilitating external audits/inspections.
  • Supplier Communication: Manage the Supplier notification system to ensure effective communication and delegation within the supplier team, ensuring Quality Compliance Assessments are appropriately assigned.
  • Metrics Development: Create and maintain metrics to track audit schedules, completion timelines, and overdue audits.
  • Risk Identification: Compile and communicate common audit findings to identify potential risk areas across the supplier network.
  • Proactive Audit Planning: Strategically plan to maintain audit schedules and prevent overdue audits.
  • Business Development Support: Collaborate with Quality management to ensure quality systems are aligned with cGMP manufacturing processes for products ranging from pre-clinical to commercial stages.
  • Cross-Functional Collaboration: Foster relationships with various departments, including Procurement, Sites, and Supply Chain, to identify and mitigate risks effectively.
  • Regulatory Adherence: Ensure compliance with FUJIFILM's procedures and regulatory standards for supplier quality management.
  • Supplier Audit Support: Assist in audit preparations, follow-up actions post-audit, and manage supplier-related documentation.
  • Training Compliance: Ensure all training and site actions are up to date, supporting other Quality Assurance teams as needed.
  • Global Supplier Assurance: Represent the organization in joint audits and continuous improvement initiatives.
  • Perform additional duties as assigned.

Required Skills and Qualifications:

  • Strong written and verbal communication abilities.
  • Exceptional organizational, analytical, and report writing skills.
  • Capability to establish personal performance objectives and contribute to departmental goals.
  • Proficient in multitasking and prioritizing tasks effectively.

Working Conditions:

The role may involve physical demands typical of an office environment, including prolonged periods of sitting, standing, and potential exposure to various materials. Reasonable accommodations will be made for individuals with disabilities to perform essential job functions.

Minimum Qualifications:

  • ASQ Quality Auditor Certification with a minimum of three years of auditing experience.
  • Experience in an auditing capacity within the Pharmaceutical or Medical Device sectors.
  • Bachelor's degree in Life Sciences or Engineering.
  • Familiarity with Good Documentation Practices and cGMP/GLP regulations.

Preferred Qualifications:

  • Knowledge of EU EudraLex Volume 4 GMPs, FDA regulations, ISO standards, and other international guidelines relevant to pharmaceutical and medical device products.
  • Understanding of industry guidelines such as ICH Q7, GHTF, and IPEC.
  • Previous leadership or supervisory experience.

At FUJIFILM, we are committed to advancing the future of medicine, empowering our employees to pursue ambitious goals and continuously enhance their capabilities. We are a company driven by a collective desire to improve ourselves, our families, our workplace, our organization, our community, and the world at large.

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