Quality Assurance - Supplier Quality Manager - Fujifilm

• Summary:  The Quality Assurance (QA) Supplier Quality manager will be responsible for leading the supplier quality team.  The manager will ensure all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility.

Essential Functions:

• Leadership
  • Provides direction to the validation team to ensure the organization is complying with local and global quality standards, regulatory requirements and partner commitments.
  • Develop, motivate and lead direct reports towards achieving organizational and individual goals.
  • Work collaboratively with management of other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principle
• Compliance
  • QA representative to external suppliers
  • Interface and coordinate with sister sites on supplier quality system, harmonization, and joint qualification
  • Maintain approved supplier list
  • Process/track complaints to suppliers
  • Develop and issue weekly and monthly metric reporting on supplier performance
  • Provide audit support when needed
  • Participate in Material Review Board (MRB) review of nonconforming product; recommend disposition and corrective action.
• New Business Growth
  • Support client due diligence and Quality audits as well as regulatory inspections.
  • Work with Quality management to implement and grow phase-appropriate quality systems that will enable cGMP manufacturing of pre-clinical to commercial products.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.
• Ability to work independently with little supervision.
• Proficient in Microsoft Excel, Word and PowerPoint.
• All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
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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 the 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, dusts, 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.
• Lifting up to 25 pounds on occasion.
• 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 manufacturing activities.
• Must be willing to travel occasionally, as needed.
• Attendance is mandatory.

Qualifications:

• Master’s degree preferably in a science-related field with four (4) years of related experience, including qualification validation experience, and two (2) years of supervisory experience: OR
• Bachelor’s degree preferably in a science-related field with six (6) years of related experience, including qualification validation experience, and two (2) years of supervisory experience.
• At least 4 years of cGMP experience.

Preferred Qualifications:

• Degree in Biology, Chemistry or Engineering
• Certified Quality Auditor
• Six Sigma Green/Black Belt cGMP 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 e-mail FDBTHR@fujifilm.com or call 979-431-3500.