QA Supplier Lead Auditor - Fujifilm

Overview

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FDB call Genki. 

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

Summary:  As an integral member of the Global Supplier Quality Management team, the Supplier Quality Auditor Lead will be responsible for managing and leading the Supplier auditors performing Supplier Audits regionally and internationally following their assigned schedule in support of supplier integrity and oversight. The Supplier Quality Auditor Lead is responsible for supporting all associated supplier quality management and audit responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs.

External US

Essential Functions:

• Leadership
• Work collaboratively with site management to instill a ‘Quality Culture’ by coaching in applying GMP Principles including the underlying rationale of those principles.
• Leadership for the FDBT Supplier Auditor Team performing audits, generation of audit reports, and management of supplier CAPA to ensure required actions are completed within the required timeframe.
• Compliance Delivery
• Support to 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.
• Development of metrics to provide visibility of audits due, planned audit dates, Audits complete, Audit reports process timelines, and overdue audits.
• Development for collation and communication of 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.
• New Business Growth
• Work with Quality management to ensure quality systems support cGMP manufacturing of pre-clinical to commercial products.
• Collaborate, align, and foster cross-functional business relationships within Global functional groups such as Procurement, Sites, and Supply Chain to ensure any risks are identified, mitigated, and communicated.
• Adhere to Fujifilm Diosynth procedures and regulatory requirements for supplier quality management.
• Support supplier quality management activities to be in a state of continued compliance.
• 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.
• Ensure no overdue training, or site actions. Support other QA teams and other functions in the completion of site actions.
• Support Global Supplier Assurance – to participate and represent the Texas Site in supporting joint audits and continuous improvement projects.
• All other duties as assigned.

Required Skills & 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.

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.  While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, some bending, stooping, and stretching.
• Ability to sit for long periods to work on a computer.
• Potential for exposure to chemicals, gases, fumes, odors, dust, and other hazardous materials.
• Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material, and appropriate shoes required in most areas associated with this position.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Must be willing to work flexible hours.
• Ability to work weekends and off-shift hours, as needed to support business needs.
• 40% travel expectations annually (domestic & international).
• Attendance is mandatory.

Minimum Qualifications:

• 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.

Preferred Qualifications:

• 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

Join us!  FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential.  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.  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 FDBTHR@fujifilm.com or call 979-431-3500.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.