Quality Assurance Associate Manager - Client Audit and Regulatory Inspection

Overview

The Quality Assurance (QA) Associate Manager of Audit & Inspection, will be responsible for the hosting and managing client audits, regulatory inspections, internal audits, and supplier assurance. The Associate Manager will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.

External US

Essential Functions:

Leadership

Mentors and provides direction to the QA compliance organization to ensure 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 principles.

Compliance Delivery

QA leadership and support to the organization in conducting audits and hosting audits/inspections

New Business Growth

Support client due diligence and Quality audits as well as regulatory inspections.

Work with Quality management to implement quality systems that will enable cGMP manufacturing of pre-clinical to commercial products.

Compliance

Responsible for managing and reporting all aspects of a fully functional GxP-QA audit program for clinical and commercial CDMO.

Manage the external and internal Audit Programs to assure that all are in an acceptable state of compliance.

Responsible for audit preparations, conducting internal audits, hosting client audits, developing and coordinating responses to client audits, regulatory inspections, and to ensure supporting documentation, tracking and verification of CAPA commitment implementation.

Provide and manage metrics and the implementation tracking of corrective and preventive actions in follow-up to audits and inspections.

Support Global Supplier Assurance - work with the global team to participate and represent Texas Site in supporting joint audits

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.

Develop staff to maximize contributions to the team and the company.

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.

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 with at least five (5) years’ industry experience in a GMP / GxP, or a comparable federally regulated environment, of which four (4) years are in a supervisory or managerial role.

Bachelor’s degree with at least seven (7) years’ industry experience in a GMP / GxP, or a comparable federally regulated environment, of which four (4) years are in a supervisory or managerial role.

Experience with direct dealings with the FDA, MHRA and other European or world-wide regulatory agencies.

Preferred Qualifications:

Certified Quality Auditor

Degree in Biology, Chemistry or Engineering

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.