Supervisor Quality Assurance Compliance – External Audits

FUJIFILM Holdings America Corporation; College Station (TX); On-site; USD 60,000 - 100,000; Full time

Job summary

Join a forward-thinking company dedicated to advancing tomorrow’s medicine. As a Supervisor in Quality Assurance Compliance, you will play a crucial role in ensuring regulatory compliance and fostering a culture of quality. This role involves supervising a team, leading audits, and collaborating with cross-functional teams to address compliance gaps. You will have the opportunity to make a real difference in the biopharmaceutical industry, supporting the development of life-changing therapies. If you're passionate about quality assurance and want to be part of a mission-driven team, this position is for you!

Qualifications

• Master’s or Bachelor’s degree in a science-related field with relevant industry experience.
• Minimum of three years auditing experience required.

Responsibilities

• Supervise QA compliance professionals and ensure regulatory compliance.
• Lead internal audits and provide QA support during inspections.

Skills

Excellent written and oral communication skills

Excellent organizational skills

Analytical skills

Data review and report writing skills

Ability to multitask

Ability to prioritize work

Education

Master’s degree in a science-related field

Bachelor’s degree in a science-related field

Associate’s Degree in a science-related field

High School Diploma or equivalent

Tools

GMP Principles

cGMP manufacturing processes

Job description

Position Overview

The Supervisor Quality Assurance Compliance – External Audit will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance. The teams are broken up into two core functional groups: One will be overseeing the successful delivery of internal audits and the other one will be overseeing the successful delivery of external audits. You will be assigned to supervise one group or the other but may be asked to provide support to the whole Audit & Inspection group on occasion.

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies 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.

Job Description

Essential Functions:

• Leadership
• Work collaboratively with site management to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
• Mentor peers towards achieving organizational and individual goals.
• Provide guidance and support to teams on compliance-related matters, including training and education initiatives.
• Supervise and mentor a team of QA compliance professionals, providing guidance, training, and coaching as needed.
• Foster a culture of quality and compliance within the team, promoting teamwork, accountability, and continuous learning.
• Lead backroom during inspections as needed.
• Compliance Delivery
• QA support to the organization during internal and regulatory inspections to determine suitability, effectiveness, and compliance with applicable standards and regulations.
• Displays critical thinking expertise, with the ability to define and implement a strategic approach to audit- based on compliance and business knowledge.
• Develop and maintain a robust QA compliance program in alignment with regulatory requirements and best practices.
• Review and update quality policies, procedures, and guidelines to ensure compliance with changing regulations.
• New Business Growth
• Support internal audits as well as regulatory inspections.
• Work with Quality management to ensure quality systems support cGMP manufacturing of pre-clinical to commercial products.
• Compliance
• Ensure self-have no overdue training, or site actions. Support other QA teams and other functions in completion of site actions.
• Provide cGMP guidance to other functions such as Manufacturing, Facilities and QC, Warehouse and Validations.
• Support Site Readiness Preparation for Regulatory Inspections.
• Staying aware and up to date with agency regulations, guidance documents, and industry best practices, to ensure Fujifilm, Texas site is held to current standards
• Execute audit strategy and lead process audits
• Monitor quality in support of maintaining inspection readiness
• Provides support during regulatory inspections or customer audits as requested by the company, before, during and/or after the event.
• Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Prepare detailed audit and inspection reports documenting findings, observations, and recommendations for corrective actions.
• Ensure accurate and timely documentation of all internal audit and inspection activities, including tracking and follow-up on corrective actions.
• Collaborate with cross-functional teams to address compliance gaps and implement process improvements.
• Ensure audit and inspection reports are responded on time.
• Works on complex problems in which analysis of situations or data requires in-depth evaluation of various factors from many sources. Is adept at interpreting GMP regulations in the resolution of problems and in the design of systems, processes or procedures.
• Ability to effectively plan, organize, and execute work that ensures deliverables are consistently met
• Continuous Improvement
• Stay informed about industry trends, regulatory changes, and best practices related to quality assurance and compliance.
• Proactively identify opportunities for process improvement and recommend strategies to enhance the effectiveness and efficiency of quality systems.
• Participate in quality improvement initiatives, root cause analysis, and risk assessment activities.
• All other duties as assigned.

Qualifications:

• Master’s degree preferably in a science-related field with three (3) years industry experience in a GMP / GxP, or a comparable federally regulated environment; OR
• Bachelor’s degree preferably in a science-related field with five (5) years of industry experience in a GMP / GxP, or a comparable federally regulated environment; OR
• Associate’s Degree preferably in a science-related field with seven (7) years of industry experience in a GMP / GxP, or a comparable federally regulated environment; OR
• High School Diploma or equivalent and nine (9) years of industry experience in a GMP / GxP, or a comparable federally regulated environment.
• All above must include at least two (2) years experience in a supervisory/managerial role.
• At least three (3) years of auditing experience.

Preferred Qualifications:

• Certified Quality Auditor
• Degree in Biology, Chemistry or Engineering

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 the essential functions.

• Experience prolonged standing, some bending, stooping, and stretching.
• 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 at the College Station, Texas site.

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.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail] or [phone]).