QA - Director Quality Compliance - Fujifilm : Job Details

Position Overview

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-systems: Internal Audit, External (Customer) Audit, Health Authority Inspection, and Remediation. 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.

Job Description

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 Compliance team to deliver exceptional performance of each assigned sub-system:
  • Internal Audit
  • External (Customer) Audit
  • Health Authority Inspection & Remediation
• 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:

• 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

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.