Senior Manager Quality Control

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