Summary: The Senior Quality Assurance Compliance - Internal 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.
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. While performing the duties of this job, the employee is regularly required to:
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.
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 email FDBTHR@fujifilm.com or call 979-431-3500.