Qc Manager, Analytical Instrumentation Validation

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.

About This Role

This role will manage the setup, routine operations and continuous improvement of the Instrument qualification and maintenance program for analytical instruments in QC.  This role is responsible for managing and developing a team of Analytical Instrumentation specialist, supporting data integrity initiatives and overseeing analytical instrument planning, purchase (CAPEX), and budget for analytical instruments in QC. This role will be responsible for cross-functional collaboration to inform management and key stakeholders of timelines and other relevant information related to instrument qualification and maintenance of analytical instruments

What You’ll Do

• Development, creation, management and oversight of the instrument qualification , instrument system lifecycle and maintenance programs/activities for QC and Manufacturing analytical instruments.
• During the project phase of the site, responsibilities will include hiring and training analytical instrument validation team, establishing/authoring procedures for analytical instruments.
• During project phase, responsibilities may include activities outside of analytical instrument validation to support setup of the QC department to meet site project timelines, authoring validation protocols and reports, and executing analytical instrument validations as needed to meet project time lines
• Manage and develop the QC Instrumentation team including resolving any issues within the QC instrumentation team. This includes but is not limited to assurance that individual and team goals are aligned with the department and corporate goals
• Initiate and follow up on excursions and deviations and initiate and corrective and preventive actions (CAPAs) related to analytical instruments.
• Support stakeholders with issues and guidance related to analytical instruments.
• Manage the planning and annual operating budget for team, annual CAPEX budget for QC and manufacturing analytical instruments, and purchasing (CAPEX) and coordination of analytical instruments
• Oversee management of vendors performing maintenance activities on analytical instruments.
• Review and approve SOPs, technical reports, KNEAT protocols and reports related to analytical instruments.
• Oversight and continuous improvement of the analytical instrument qualification program, including SOPs, Kneat and other relevant systems.
• Inform key stakeholders of timelines and other relevant information related to instrument qualification and maintenance of analytical instruments.
• Support data integrity initiatives related to analytical instruments.
• Represent area during internal and external inspections/audits
• Collaborating across different sites to align policies and best practices for instrument validation
• Perform other tasks as assigned.

Minimum Requirements:

Bachelor’s degree required, preferably in Chemistry, Microbiology, Biological Sciences, Engineering or related science degree plus 12+ years of related experience in regulated environment. 

Master’s Degree in Chemistry, Microbiology, Biological Sciences, Engineering or related science degree with 8+ years of experience 

Ph.D. in Chemistry, Microbiology, Biological Sciences, Engineering or related science degree with 5+ years of experience  

• Knowledge related to instrument qualification, data integrity and regulatory guidance such as FDA CFR 21 part 11, Eudralex annex 11 and 15 etc.
• At least 7 years of practical qualification/validation Experience
• At least 7 years of experience from a GMP environment
• Prior Experience in Leadership Position 

Preferred Requirements:

• Experience with KNEAT and laboratory LIMS

FDBN 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. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

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.