Associate Director QA for Materials, Supply Chain and QC

The Associate Director, QA for Materials, Supply Chain and QC will be responsible for the supervision of the Quality teams supporting release of materials, Supply Chain functions including warehouse as well as providing Quality oversight for the QC function via supervision ensure that materials released are tested in accordance with GMP regulations. Provides QA support for approval of specifications, documentation, reports, deviations, and changes coming from the QC function. Assures product compliance through Quality systems and effectively ensure initiatives that promote a robust Quality Culture within Quality function and for supporting functions. Proactively engage with the organization to drive continuous improvements within the team. As member of the site Quality leadership team contribute to cohesive execution of quality initiatives and projects throughout the site in Holly Springs.

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

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 FUJIFILM Diosynth Biotechnologies and help manufacture 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 we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

Job Description

What You'll Do

• Manages QA for Materials, Supply Chain and QC team which includes release of materials, Supplier Quality program and support for QA for QC team. Supervision includes planning, goal setting and supervision of personnel in accordance with company goals.
• Provides QA oversight and support for QC and Supply Chain including Warehouse and ensure team is staffed with adequate resources and skillsets to support these areas.
• Collaborates with Global QA teams including Supplier Quality and external audit teams to implement and ensure adherence with global programs and needs.
• Ensures alignment with other QA functions in driving continuous improvements and Quality mindset activities across the site.
• Provides resources for Supplier Quality Function execution of external audits, supplier complaints, Quality agreements for suppliers,
  
  

vendor/supplier changes to support both local and global needs for this area.

• Provides Quality oversight and approval of system and process lifecycle documentation, including risk and impact assessments for processes and equipment. This also includes QA approval of documentation, changes, deviations and CAPAs for the areas.
• Ensures strong collaboration with operational peer network and promote a strong Quality culture for the site.
• Generates, reviews and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of
  
  

manufacturing operations in cGMP regulated facility including trend reports for process for QC and Supply Chain activities.

• Ensures training needs for the team are met and complies with GMP guidelines for the QA function within area of responsibility.
• Ensures that project and operational quality objectives are met within desired timelines.
• Collaborates and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency.
• Develops and supports start up activities into operations as the project matures, such as system optimization or improvement initiatives and supporting regulatory agency and third-party inspections.
• Coaches and mentors’ direct reports and team members to foster professional development and growth.
• Enforces and ensures team adheres to company policies and procedures.
• Participates in the recruitment process to attract talent.
• Collaborates with Human Resources (HR) and Talent Acquisition and provides input to develop retention strategies.
• Addresses employee concerns and partners with HR for resolution, as needed.
• Evaluates team performance and address gaps appropriately.
• Performs Other duties, as assigned
  
  

Minimum Requirements:

• Bachelor’s degree in Engineering, Life Sciences with 12 years of related experience (e.g., Statistical Control of Manufacturing
  
  

Processes or Development of Data Collection/Management Systems) OR

• MS degree in Engineering, Life Sciences with 10 years of related experience (e.g., Statistical Control of Manufacturing Processes or
  
  

Development of Data Collection/Management Systems) OR

• Ph.D. with 8 years’ experience
• 8 years of people management and leadership experience
• Experience working in a GMP environment
  
  

Preferred Requirements:

• Experience collaborating and interacting with a global team.
• Experience with multivariate data analysis
  
  

Physical and Work Environment Requirements:

Ability to discern audible cues.

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

Ability to stand for prolonged periods of time up to 60 minutes.

Ability to sit for prolonged periods of time up to 60 minutes.

Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).