QA - Director Quality Systems

The Director Quality Systems is responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT.  Responsibilities will include one or more PQS sub-system: Deviation, CAPA, Change Control, Supplier Quality, Training, Document Control, QA Validation, eQMS, and Quality Management.  Lead the assigned team to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders.  Ensure the site PQS sub-system is aligned with the harmonized global FDB PQS, organizational goals and objectives, and areas of continuous improvement.

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. 

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

Essential Functions:

• Develop, implement, and maintain the risk-based PQS sub-systems to meet all CGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture.

• Establish governance and oversight processes to ensure the organization is continuously complying with site and global quality standards, regulatory requirements, and partner commitments.

• Lead the Quality Systems team to deliver exceptional performance of each assigned sub-system.

o Deviation, CAPA, Change Control

o Supplier Quality

o Training

o Document Control, eQMS

o QA Validation

o Quality management

• Liaise with internal and external stakeholders to achieve expected business outcomes.

• Partner with Quality Compliance to ensure the site is inspection ready at all times.

• Implement audit/inspection learnings within the site QMS; share learnings between FDB sites.

• Identify areas of risk and/or continuous improvement; escalate/communicate as appropriate.

• Provide expert guidance and interpretation on regulatory requirements.

• Recruit, hire, and manage the team in line with FDBT policies and practices.

• Ability to serve as deputy for Senior Director Quality Systems.

• Any other duties as assigned.

Required Skills & Abilities:

• Expert understanding of Pharmaceutical Quality Systems.

• 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.

• All candidates must have a working knowledge of CGMP regulations for the production of drug substance, drug product, biologics, vaccine, and/or advanced therapy 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.

• 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.

Qualifications:

• Bachelor’s degree with 10 years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment; OR

• Associate’s degree with 12 years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment.

• At least 6 years of experience in a supervisory or managerial role.

• A minimum of 5 years of experience working with biologics (vaccines, gene therapy, mAb, etc.) in a QA or QC role.

Preferred Qualifications:

• Experience with biologics – vaccines, gene therapy, mAb, etc.

• Experience within CDMO

• Advanced Degree

• ASQ Certification