Position Overview

FUJIFILM Biotechnologies Texas is seeking a Senior Quality Assurance Specialist, Quality Risk Management (QRM) will be the Local Business Process Owner for Quality Risk Management, responsible for the execution and management of the QRM program elements, including but not limited to, creation of procedures, work instructions, forms/templates, etc., leading/facilitating QRM assessments, collaborating with key stakeholders to ensure all elements of QRM are carried out through established work practices, and ensuring consistent application of QRM system compliance with FLBT local/global procedures and policies, and applicable regulatory requirements. Executes process/continuous improvement and supports new technology initiatives. Contributes to and leads in the development, implementation, and successful execution of the QA mission, objectives, and 3–5-year strategic plan. The ideal candidate will have strong technical expertise in eQMS systems and experience with quality system validation and compliance.

Job Description

Reports to                Quality Assurance Governance Manager

Work Location         College Station, TX 

Primary Responsibilities:

Quality Risk Management:

• Execute daily program level responsibilities, including development and implementation of QRM processes and continuous improvements to ensure productivity and alignment with departmental/site/global goals.
• Drive a culture of continuous quality improvement across the organization, leading initiatives that enhance service delivery and patient care.
• Establish and foster a cGMP quality culture that prepares the site for regulatory pre-approval inspections and eventual licensure for commercial manufacturing.
• Manage multiple assigned projects concurrently.
• Provide support to Manufacturing, Facilities, Supply Chain, and other supporting function stakeholders to ensure QRM processes are utilized as required.
• Prepare and provide comprehensive reports on quality and risk management activities, utilizing performance metrics to identify areas for improvement.
• Assist in the implementation of global systems for the QRM program, including implementation and release of future changes / QRM system.
• Provide collaboration and guidance for the development and continuous improvement of QRM training to ensure QRM compliance, as well as specialized QRM facilitator training across all GxP functions.
• Leads risk assessments to identify and address key quality issues, ensuring risks are escalated and managed appropriately within FUJIFILM Biotechnologies Texas.
• Performs other duties as assigned.

Collaboration & Continuous Improvement:

• Represent the QRM group in cross-functional meetings and global quality risk management initiatives as needed.
• Represent FLBT QA on the Global QRM team as assigned.
• Collaborate with Global and Local Business Process Owners and system SMEs to optimize QRM program, ensure compliance, and drive continuous improvement.
• Promote a “Quality Culture” by supporting CGMP principles and best practices across departments.
• Build relationships and initiate collaboration with key counterparts, functional area leaders, and stakeholders across FUJIFILM Biotechnologies Texas to establish and identify process improvement initiatives and to identify, assess, and prioritize risks across all operations, implementing strategies to mitigate these risks effectively.

Audit and Regulatory Support:

• Participate and represent the company in regulatory inspections and audit activities conducted by third-party and corporate partners as process owner for QRM.
• Participate in client due diligence, quality audits, and regulatory inspections.

Required Skills & Abilities:

• Experience building, executing, integrating, leading, and maintaining QRM systems.
• Proven QA experience including successful implementation and oversight of Quality Management Systems, inspection readiness and health authority inspection management in a cGMP biologics manufacturing environment.
• Ability to proactively predict and resolve complex problems, think strategically and tactically, and to execute/implement solutions to complex problems.
• Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Expert level knowledge of US and International GMPs, FDA/ICH Guidance, and best practices in a biotech manufacturing and testing environment
• Proven ability and enthusiasm to lead, motivate, inspire, develop, and encourage colleagues.
• Interacts with senior management or executive levels on matters concerning several functional areas.
• Strong analytical, communication, and negotiation skills as well as sound judgment, with the ability to work effectively with others.
• Must be self-motivated with ability to handle, organize and prioritize multiple tasks and be able to perform under pressure to meet production deadlines.
• Experience with Quality Systems (Deviation, Investigation, CAPA, Change Control, Audits, etc.).
• Strong organizational skills with excellent attention to detail and ability to manage multiple priorities.
• Strong problem-solving, project management, and decision-making skills.
• Proficiency in MS Office (Word, Excel, Outlook) and quality system software.
• Advanced computer skills with working knowledge of MS office such as Word, Excel, and Adobe Acrobat Strong analytical and problem-solving skills.
• Role model for company core values of trust, delighting our customers, and Gemba.

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:

• Must be willing to work flexible hours.
• Experience prolonged standing, some bending, stooping, and stretching.
• Ability to sit for long periods to work on a computer.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Attendance is mandatory.

 Qualifications:

• Master’s degree preferably in a science-related field with 3+ years of related experience; OR,
• Bachelor’s degree preferably in a science-related field with 5+ years of related experience; OR,
• Associate’s degree preferably in a science-related field with 7+ years of related experience.
• 3+ years of cGMP experience or Quality Risk Management.

Preferred Qualifications:

• Previous leadership experience.
• Working knowledge of FDA (21CFR 210, 211 & 820) and EU regulatory requirements
• Certifications such as Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or similar are a plus.
• Experience in developing cGMP high growth, and fast-paced environment.
• Experience in Quality Systems in a development and commercial site.