Quality Assurance-Associate Director, Compliance

Overview

Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)

 

The work we do at FDB 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 FDB call Genki

 

Summary:  The Associate Director (AD), Compliance will be responsible for the overall performance of the Quality Systems group and support all other functions within the QA Compliance Team.  The AD will handle all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance. 

External US

Essential Functions:

• Leadership
  • Mentors and provides direction to the QA compliance organization to ensure organization is complying with local and global quality standards, regulatory requirements and partner commitments.
  • Develop, motivate and lead direct reports towards achieving organizational and individual goals.
  • Work collaboratively with management of other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
• Compliance Delivery
  • QA leadership and support to the organization in conducting deviation investigations, CAPAs, Change Controls, to be compliant and on-time.
• New Business Growth
  • Support client due diligence and Quality audits as well as regulatory inspections.
  • Work with Quality management to implement and grow phase-appropriate quality systems that will enable cGMP manufacturing of pre-clinical to commercial products.
• Compliance
  • Solid understanding and able to provide leadership to Deviations, CAPAs, Change Controls, Training, Data Integrity, QAVal, Inspections & Audits, and Supplier Quality.
  • Ensure self, and department have no overdue training, or site actions. Support other QA departments and other functions in completion of site actions.
  • Provide cGMP guidance to other departments such as Manufacturing, Facilities and QC.
  • Utilize investigative techniques to determine root causes of deviations and proper corrective and preventative actions.
  • Review and/or approve basic and technical documentation to include, but not limited to:
    • Standard Operating Procedures
    • Commissioning, qualification and validation protocols and reports
    • Deviation Reports, Corrective Action/Preventive Action Plans and Change Controls
  • Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• All other duties as assigned.

 

Required Skills & Abilities:

 

• 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, biologics or vaccine 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.
• Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.
• 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 appro