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:
- Mastery knowledge of document management and lifecycle
- Mastery knowledge of quality systems and their interconnections
- Mastery knowledge of how to control, request, receive and/or distribute product/samples
- Mastery knowledge of product testing, data analysis, and reporting
- Advanced knowledge of sampling plan lifecycle and inventory management
- Advanced knowledge of computer systems (e.g., Word, Excel, LIMS).
- Experience in Smartsheet, statistical analysis, and/or statistical analysis software (i.e., JMP), is a plus.
- Advanced knowledge of regulations and inspection/audit readiness
- Advanced knowledge of QMS (CAPA, deviation, change control, laboratory investigation)
- Expert understanding in verbal and written communication, customer-service oriented
- Expert understanding in problem solving and critical thinking
- Expert understanding in project management, teamwork & collaboration
- Expert understanding in decision making
Education and Professional Experience:
- 5+ years of team management experience
- Bachelor of Science (B.Sc.) with 10+ years of experience 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
Salary and Benefits:
- $150k to $165k per year, depending on experience
- Medical, Dental and Vision
- Life Insurance
- 401k
- Paid Time Off
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.
FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.
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.
