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Sr. Director Quality Operations

2 weeks ago

Hamilton, New Zealand FUJIFILM Holdings America Corporation Full time
Position Overview

The Senior Director Quality Operations is responsible for QA oversight of CGMP manufacturing operations and areas at one of our manufacturing facilities at FDBT. Lead the Quality Operations organization to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders. Direct all QA on-the-floor (QAOTF), batch record review (BRR), and product disposition activities including QA review and approval of any associated deviations, CAPAs, and change controls to meet established targets for right first time execution and on-time delivery. Ensure products are manufactured to meet all CGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture.

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:

  • Develop, implement, and maintain QA oversight activities to meet all CGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture.
  • 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.
    • Readiness activities before manufacture.
    • Oversight activities during manufacture.
    • Review activities after manufacture.
  • 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 FDBT policies and practices.
  • Ability to serve as deputy for VP Quality.
  • Any other duties as assigned.

Required Skills & Abilities:

  • 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 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.
  • 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.

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:

  • 12+ years of team management experience
  • Bachelor’s degree with 12+ years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment; OR; Associate’s degree with 14 years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment.
  • 7+ years of experience working with biologics (vaccines, gene therapy, mAb, etc.) in a QA or QC role.
  • Strong leadership, collaboration, team building, program management and organizational skills.
  • Strong verbal and written communication and strong analytical skills.
  • Proven ability to develop, communicate and execute plans and strategies with a wide range of stakeholders.

Preferred Qualifications:

  • Experience within CDMO
  • Advanced Degree
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