Quality Assurance Supervisor - Compliance, Training and Data Integrity

Summary:  The Quality Assurance (QA) Supervisor, Training and Data Integrity, will be responsible for all aspects governing and overseeing GxP training and Data Integrity.  The supervisor will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance. 

External US

Essential Functions:

Leadership

• 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.
• Develop staff in delivering effective training and data integrity programs.
• Oversee external contractors supporting training and data integrity.
• New Business Growth
• Support client due diligence and Quality audits as well as regulatory inspections.

Compliance

• Developing, maintaining and driving continuous improvements while providing quality oversight of the GxP training program which includes:
• Develop and oversee quality orientation training for new GxP employees as part of the on-boarding process and annual GxP refresher training.
• Development and management of training curricula.
• Development and oversight of the “Train-the-trainer” program for delivery of instructor-led and on-the-job training/Skills Demonstration Assessments.
• Supervise, coach and develop trainers across the site to ensure training effectiveness.
• Collaborate with process owners and departments to create effective training material.
• Maintain training records to meet all regulatory requirements.
• Supervise staff including development and monitoring training system metrics.
• Identifies and analyzes new GMP enforcement requirements and trends and their impact.
• Provides oversight and participates as the Subject Matter Expert for the GxP training program during audits and inspections.
• Partner with the global and site organization on the development of audit responses and corrective actions related to GxP training.
• Supervises, Develops and oversees the Data Integrity program which includes:
  • Design and implementation of new processes and controls to establish clear functions, responsibilities, accountabilities and expectations to ensure data integrity
  • Review and rectify data integrity gaps using risk assessments and risk registers.
  • Manage and oversee corrective actions
• Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• 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.
• Must have strong 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
• Attendance is mandatory.

Qualifications:

• Bachelor's degree with 7 years of related experience and one (1) year of lead or supervisory experience; OR
• Associates degree and/or 10 years of related experience and one (1) year of lead or supervisory experience
• At least 5 years of cGMP experience.

Preferred Qualifications:

• 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.