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Director, Quality Assurance

Research Triangle Park, North Carolina

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We’re 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. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.

As we grow our community, our capacity, and capabilities significantly in the next year, we’re looking for passionate people to join our global team.

The incumbent is responsible for day to day management of the Quality Assurance center of excellence and is responsible for hiring, managing performance, and development of reporting staff. The individual is recognized as a subject matter expert with regard to Quality Assurance practices and procedures and serves as the point-of-contact for Integrated Production Team (IPT) and Center of Excellence (COE) activities for the QA group. In this capacity, the incumbent is a primary point of contact for QA and is responsible for planning, scheduling, and organizing QA activities related to meeting the compliance, supply, profit plan, and strategy objectives of the company and the department. The individual initiates and oversees projects aimed at cost reduction, efficiency improvements, minimization of downtime and quality or safety enhancement.  The incumbent makes recommendations regarding departmental profit plan, capital planning, budget, and standards development. The incumbent recognizes and investigates opportunities for financial savings across a broad spectrum of operational activities.  In this role, the individual must be able to identify and communicate improvement opportunities and results. The incumbent identifies operational needs for projects, ensuring site/divisional linkage is achieved. The incumbent must be able to identify and address short term, intermediate, and long term issues, and be able to appropriately resolve conflict and prioritize work as necessary. The incumbent may have individual contributors and/or hourly support staff reporting to them.

 

Main areas of responsibility include, but are not limited to:

  • Responsible for all activities related to the QA Operations group, including the “QA on the floor” effort to continue to improve the “right the first time” documents flow off the production and laboratory floor.
  • Responsible for assuring cGMP requirements documents are in place at the site and the control, archiving and retrieval of those documents is achieved.
  • Drive continuous improvement LSS efforts and problem solving sessions for documentation programs and serves as QA lead for the short and long term cGMP document system redesign and implementation
  • Direct, develop and evaluate team members to assure all individuals in the QA Operations group reach their potential.
  • Responsible for contributing to the establishing of the site quality goals and setting direction for continuous compliance improvement.
  • Responsible along with the Responsible Person(s) for assuring that all batches of clinical and commercial material are suitable for use per all applicable cGMP requirements, agency filings, quality agreements and requirements specifications as well as the site Material Review Board activities needed to disposition material.
  • Responsible for coordinating the site Quality Assurance budget.
  • Responsible for the site QA Operations quality system integration activities with other FDB sites
  • Responsible for participation in internal audits, client audits and agency inspections of the site which includes the satisfactory execution, follow up, and closure of inspection and audit items to the satisfaction of all parties.
  • Other duties as requested.

 

 

MAJOR ACTIVITIES AND RESPONSIBILITIES:

  1. Schedules, coordinates, and manages daily activities related to profit plan, revenue, supply, and compliance – 20%
  2. Personnel development- coaching, training, performance management – 40%
  3. Logistical and strategic support for developing and implementing business process improvements – 40%

 

 

SCOPE MEASURES:

The director may supervise 10 or more exempt or non-exempt staff. The director contributes to the development of the capital and expense budget and have approval authorities as defined in the company’s authorization matrix. The director is responsible for managing the department activities in a manner that meets or exceeds the company objectives regarding revenue, profit plan, supply, and compliance.

 

BACKGROUND REQUIREMENTS:

 

  • Minimum Education Requirements
  • BS/BA in sciences, preferably in chemistry, biochemistry, microbiology, biotechnology, pharmaceutical sciences, or related technical field
  • Masters or PhD in Science or Quality would be an asset

 

Desired Experience

  • 10+ years related GMP and quality systems experience (8 years required with relevant MS or PhD degree) in chemistry, biochemistry, microbiology, pharmaceutical, biotechnology, or manufacturing or laboratory environment, including 5 years supervisory experience
  • Experience working in a lean manufacturing or six sigma environment

 

Specific Skills and Competencies

  • Ability to interpret cGMPs and apply to non-routine situations
  • Demonstrated leadership, technical aptitude, and problem solving skills
  • Must be flexible and able to manage and prioritize multiple tasks and assignments.
  • Must have excellent verbal and written communication skills and comfortably and clearly articulate issues with peers and colleagues at all levels in the organization.
  • Demonstrated capability in cross functional team environment, working collaboratively with others in effective ways that attain goals while encouraging teamwork and synergies throughout the organization
  • Demonstrated capability in coaching and development of personnel
  • Ability to consider the customer’s perspective
  • Capable of high through-put and high quality, Right First Time work
  • Certified or capable of timely certification for Yellow Belt in six sigma or lean program
  • Demonstrated subject matter expert in quality systems
  • Ability to make informed and timely decisions independently
  • Capable of recognizing process gaps and implementing improvements
  • Leadership traits that build and foster trust, respect, cooperation, and collaboration across the organization
  • Strong team skills, including ability to coach/develop work teams, provide training, motivate/empower others, and resolve conflict.

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

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