Quality Assurance - Supplier Quality Manager

Overview

• 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.

External US

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.

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.