Senior Manager, Quality Control Operations

Overview

Join us!  FDB 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.  The Senior Manager Quality Control (QC) Operations at Fujifilm Diosynth Biotechnologies California (FDBC) oversees QC processes that support QC labs (internal and external), Manufacturing, and technical operations.  These processes include QC sample management, Certificate of Analysis/Testing, Product Specification, equipment management, external contract laboratory testing, method monitoring, quality metric review, quality records and investigations associated with QC. The Sr. Manager will interact with internal QC, Manufacturing, Quality Assurance, Warehouse and Facilities in addition to external Quality representatives supporting client requests and/or notifications. This position requires both leadership, technical, and business expertise. From a leadership perspective, the selected individual will need to lead, develop, and motivate staff. This requires a self-motivated, flexible, and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment. From a technical perspective, the selected individual will directly oversee QC Operations activities and deliverables to provide systems and processes to enable QC to complete product testing and results reporting. In addition, role model company core values of trust, delighting our customers, Gemba, and Genki.

External US

Senior Manager, Quality Control Operations

Job Type:             Full Time

City:                      Thousand Oaks (Los Angeles)

Reports to:           Director, Quality Control

Travel: Limited Travel (up to 10%).

 

Job Description:

The Senior Manager Quality Control (QC) Operations at Fujifilm Diosynth Biotechnologies California (FDBC) oversees QC processes that support QC labs (internal and external), Manufacturing, and technical operations.  These processes include QC sample management, Certificate of Analysis/Testing, Product Specification, equipment management, external contract laboratory testing, method monitoring, quality metric review, quality records and investigations associated with QC. The Sr. Manager will interact with internal QC, Manufacturing, Quality Assurance, Warehouse and Facilities in addition to external Quality representatives supporting client requests and/or notifications. 

This position requires both leadership, technical, and business expertise. From a leadership perspective, the selected individual will need to lead, develop, and motivate staff. This requires a self-motivated, flexible, and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment. From a technical perspective, the selected individual will directly oversee QC Operations activities and deliverables to provide systems and processes to enable QC to complete product testing and results reporting. In addition, role model company core values of trust, delighting our customers, Gemba, and Genki.

Primary Responsibilities:

• Manage QC activities relating to new business initiatives, strategic planning, data management, and coordination of QC Operations deliverables.
• Oversees and supports team that investigates deviations that occur in Quality Control areas.
• Supports laboratory investigations, OOS, root cause analysis, and corrective action/preventive action implementation.
• QC Operations point of contact for lot status of QC certificate of analysis/testing.
• QC Operations point of contact for new product introductions in FDBC facility.
• Oversee team of QC process owners within sample management, certificates, product specifications, equipment, method monitoring, and external contract laboratory testing.
• Review and approve documents required to support QC Operations process documents.
• Coordination of strategic and operational activities within QC including project support, coordination, collation of information, reporting, and data analysis.
• Facilitate effective communication across internal departments.
• Works closely with team members to provide effective solutions to support business and quality objectives.
• Defines and analyzes key performance metrics to drive continuous improvement across QC operations.
• Support regulatory inspections/audits.

 

Physical Requirements:

• • Subject to extended periods of sitting.

 

Position Requirements: