Director of Quality Operations

6 days ago

College Station, Texas, United States Fujifilm Diosynth Biotechnologies Full time

Job Summary:

The Director of Quality Operations will be responsible for overseeing the quality assurance of CGMP manufacturing operations and areas at Fujifilm Diosynth Biotechnologies. This includes leading the Quality Operations team to create a strong quality culture, maintaining strong working relationships with internal and external stakeholders, and ensuring products are manufactured to meet all CGMP regulatory requirements.

Key Responsibilities:

  • Develop, implement, and maintain QA oversight activities to meet all CGMP regulatory requirements.
  • Establish operational tier structure to ensure the site is continuously complying with standard operating procedures, processes, regulatory requirements, and partner commitments.
  • Lead the Quality Operations team to deliver exceptional performance of each assigned area.
  • Perform QA review and approval of deviations, CAPAs, and change controls.
  • Identify and implement best practices to improve right first time (RFT) execution.
  • Disposition products that meet all requirements on time based on established commitments.
  • 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.
  • Identify areas of risk and/or continuous improvement; escalate/communicate as appropriate.
  • Provide expert guidance and interpretation on procedural requirements.
  • Recruit, hire, and manage the team in line with Fujifilm Diosynth Biotechnologies policies and practices.

Requirements:

  • Strong understanding of 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.
  • The individual must have excellent interpersonal skills which will enable them to communicate effectively.
  • The individual must be able to work flexibly in high-pressure environments and be able to make appropriate decisions quickly if required to do so.
  • Able to build and maintain effective and credible relationships with key stakeholders and across all areas of the business.
  • The individual must possess a strong EHS and Quality compliance ethics and be able to lead by example.
  • Experience of working with and influencing senior managers and customers.

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.

Director 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:

  • At least 5 years of direct experience in some or all these areas: drug product, raw materials, warehouse, analytical, buffer/media, cell banking.
  • Experience within CDMO.
  • Advanced Degree.

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