Job Details

Position Overview

Summary:

Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking Quality Assurance (QA) Validation - Associate Director to oversee the review and approval of commissioning, qualification, and validation protocols, reports, and discrepancies. This role will ensure compliance with FUJIFILM Diosynth Biotechnologies' quality policies, site SOPs, and regulatory requirements while providing strategic leadership to the validation team.

Job Title: Quality Assurance (QA) Validation, Associate Director

Reports to: Director, Quality Assurance Compliance

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. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FUJIFILM Diosynth Biotechnologies call Genki.

Job Description

Essential Functions:

Leadership

• Develop, implement and maintain QA oversight activities to meet all GMP guidance and direction to the validation team to ensure adherence to local and global quality standards, regulatory requirements and partner commitments.
• Maintain an operational tier structure to ensure the site is continuously complying with standard operating procedures, processes, regulatory requirements, and partner commitments.
• Identify and implement best practices to improve right first time (RFT) execution.
• Develop, mentor, motivate and lead direct reports to achieve individual and organizational objectives.
• Collaborate with cross functional teams and management to instill a “Quality Culture” by coaching personnel on GMP principles and their applications.

QA Validation and Compliance

• Review and approve master validation plans, qualification/validation protocols, summary reports, and associated data to ensure regulatory and SOP compliance.
• Identify areas of risk and/or continuous improvement; escalate/communicate as appropriate.
• Oversee and approve validation deviations and discrepancies, supporting investigations and corrective actions, and participate in design reviews, assess P&IDs, and review engineering drawings for compliance.
• Collaborate with Validation, Metrology, Facilities, and Engineering teams to ensure GMP protocols and requirements are met in a timely manner.

New Business Growth

• Lead the effort to support client due diligence, quality audits, and regulatory inspections to ensure compliance with industry and company standards.
• Perform other duties as assigned.

Required Skills & Abilities:

• Proven ability to motivate and lead teams instilling our Company philosophy, culture, and People Fundamentals.
• Experience in qualification/validation of process equipment, clean utilities, automation, sterile filling, aseptic processing, HVAC systems, and new GMP facility construction.
• Strong understanding of cGMP regulations for the production of drug, biologics, or vaccine products.
• Excellent written and verbal communication skills, with strong organizational and analytical abilities.
• Excellent organizational, analytical, data review and report writing skills.
• Ability to prioritize tasks, multitask effectively, and work independently with minimal supervision.
• Develop staff to maximize contributions to the team and the company.
• Proficiency in Microsoft Excel, Word and PowerPoint.

Qualifications:

• Bachelor's degree with eight (8) years of relevant experience in a heavily regulated environment such as pharmaceutical, biotechnology, or supporting a CDMO environment; OR
• Associate's degree with ten (10) years of relevant experience in a heavily regulated environment such as pharmaceutical, biotechnology, or supporting a CDMO environment.
• At least four (4) years of experience in a leadership or prior supervisory/managerial role.
• A minimum of five (5) years of experience working with biologics (vaccines, gene therapy, mAb, etc.) in a QA or QC role.

Preferred Qualifications:

• Degree in Biology, Chemistry or Engineering.
• Single Use and Process Validation a plus.
• Previous leadership experience in Quality Control or Quality Assurance.

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.

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 (...@fujifilm.com or (979) ###-####).