Quality Assurance Director

3 days ago

College Station, Texas, United States Fujifilm Diosynth Biotechnologies Full time
Job Title: QA Senior Director Quality Systems

We are seeking a highly experienced and skilled QA Senior Director Quality Systems to join our team at FUJIFILM Diosynth Biotechnologies.

As a key member of our organization, you will be responsible for developing, implementing, and maintaining Pharmaceutical Quality Systems (PQS) that meet all CGMP regulatory requirements.

Key Responsibilities:
  • Develop and implement risk-based PQS to meet all CGMP regulatory requirements
  • Establish governance and oversight processes to ensure compliance with site and global quality standards
  • Lead the Quality Systems team to deliver exceptional performance of each assigned sub-system
  • 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
Essential Functions:
  • Develop, implement, and maintain the risk-based PQS to meet all CGMP regulatory requirements
  • Establish governance and oversight processes to ensure the organization is continuously complying with site and global quality standards
  • Lead the Quality Systems team to deliver exceptional performance of each assigned sub-system
  • 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 VP Quality
  • Any other duties as assigned
Required Skills and 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
Preferred Qualifications:
  • Experience with MasterControl, Veeva, Blue Mountain, SAP, and Trackwise
  • Experience within CDMO
  • Advanced Degree
Working Conditions and 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

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