Position Overview
Senior Manager, Quality Control is a leadership role that manages a team of individuals and activities for the Quality Control Analytical laboratory. The position requires both leadership and technical expertise. The candidate must have advanced knowledge of analytical method and testing life cycle as well as regulations governing testing by a variety of analytical methods including bioassay, cell biology, immunology, compendial, and raw material. The selected individual will need to lead, develop, train, and motivate staff. This requires a self-motivated, detail oriented, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced and demanding environment. The selected individual will participate guide and lead the team in laboratory investigations, CAPAs, deviations, and change controls supporting instrumentation and method transfer/validation activities. The candidate must possess knowledge of instrument IQ/OQ/PQ and 21CFR Part 11, CSV validation and be current with data integrity regulations as well as possess working knowledge of QMS systems, root cause analysis and method validation guideline ICHQ2.
Company Overview
Join us! FUJIFILM Diosynth Biotechnologies is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers - driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.
Job Description
Reports to: Associate Director, Quality Control
Location: Thousand Oaks, CA
Travel: Up to 10%
Primary Responsibilities:
Manage QC activities at FDBC including Product Release, In-Process, Stability and Raw Material testing.
Lead and develop a team of QC Associates/Sr Associates and Supervisor(s) in alignment with FDBC department objectives.
Participate in instrument validation and track the process lifecycle for new equipment acquisitions, transfers, and decommissions. Own or participate in CAPAs, deviations, and change controls assessments related to instrumentation.
Oversee internal laboratory instrumentation platform (s), including a periodic review of performance and repair assessments.
Establish rapport with laboratory personnel as well as facilities team and respond promptly to equipment repair requests with prioritized follow-through on necessary work orders and vendor visit for repair.
Work with laboratory personnel to troubleshoot potential instrumentation issues and be ready to open corrective maintenance work orders when applicable.
Participate in laboratory investigations involving instrumentation including Unexpected Results (UR)/Out of Specification (OOS), root cause analysis.
Establish rapport with Analytical Development team and work seamlessly in the process of new product introduction method transfers as well as phase appropriate analytical method validation.
Work closely with QC leadership to establish an effective instrument induction and new product introduction strategy including method transfer and phase appropriate validation.
Maintain current knowledge base of regulations and policies to ensure that the QC function remains in compliance with applicable company requirements and global regulations.
Interface with other departments (e.g., Facilities, Information Technologies, Manufacturing, Validation, Regulatory Affairs, MSAT, Process Development, Analytical Development and Quality Assurance) to ensure achievement of FDBCs objectives relating to QC instrumentation, method transfer and method validation.
Qualifications
Bachelor of Science (B.Sc.) with 10+ years of experience or an equivalent combination of education; or Master of Science (M.Sc.) with 7+ years of experience; or PhD in Science with 5+ years of experience
Degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology or mechanical engineering preferred.
GMP laboratory experience in a wide variety of techniques representing a variety of instrumentation.
Mastery knowledge of analytical or microbiological methods and respective instrumentation.
Prior experience and comfortable working with radioactive isotopes or radiation labs.
Mastery knowledge of computer systems (e.g., Word, Excel, LIMS).
Working knowledge of regulations and inspection/audit readiness.
Mastery knowledge of QMS (CAPA deviation change control)
Mastery knowledge of instrument IQ/OQ/PQ.
Mastery knowledge of method transfers and validation and respective guidelines.
Advanced knowledge of basic statistics and statistical software.
Must possess demonstrated organizational skills that have proven results and the ability to be self-directed while managing multiple projects.
Independent decision-making capability and ability to think conceptually and understand impact of critical decisions.
Must possess excellent communication and technical writing skills.
Team player, good interpersonal skills and a strong service-oriented mindset.
Flexibility to travel as required to accommodate the business needs.
Role model for FDBC values (Trust, Delighting our Customers, Gemba, Ghenki).
The US salary range for this position is $150,000 to $175,000. Pay within this range varies by work location?and may alsodepend on job-related knowledge, skills,?and experience.
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.
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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 (FDBCHR@fujifilm.com).
Job Locations US-CA-Thousand Oaks
Posted Date 11 hours ago (4/28/2025 2:22 PM)
Requisition ID 2025-34173
Category Quality Control
Company (Portal Searching) FUJIFILM Diosynth Biotechnologies
