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Senior Manager
Quality Control
Confirmed live in the last 24 hours
San Bruno, CA, USA
Experience Level
  • BA or B.S. degree in a science discipline required, or comparable experience. M.S. in a scientific discipline is preferred
  • Minimum of 7 years experience in a cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment
  • At least 2 years in a managerial role
  • Prior experience related to method development/validation
  • Strong background in cell biology, immunology, and molecular biology
  • Strong working knowledge of quality systems and regulatory requirements including 21 CFR Part 11/210/211
  • Must have working knowledge of controlled documentation, data systems, cGMPs, SOPs, analytical testing, and auditing
  • Identifying, authoring, and supporting OOS, DRs, and CAPAs
  • Equipment IQ/OQ/PQ experience
  • Proficient in MS Office products including, Word, Excel, Outlook, and Power Point
  • Excellent interpersonal, verbal, written communication and organization skills
  • Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
  • Must be able to commute to South San Francisco
  • Schedule/Manage routine and non-routine analysis of in-process, raw materials, finished goods, or stability samples
  • Ensure the quality control lab is held to GxP standards and safety standards
  • Create/Review and approve Certificate of Analysis
  • Conduct investigation regarding out of specifications (OOS) results and address and manage deviations related to analytical procedures
  • Review and approve data to ensure accuracy and regulatory compliance
  • Collaborate with QC Microbiology management in establishing specifications and justification of specifications
  • Create/Review and approve new and revision of analytical test methods
  • Create/Review and approve method validation protocols/reports and other documentation such as analytical reports
  • Create/Review and approve stability protocols and reports
  • Create/Review and approve quality control operation procedures
  • Manage the validation of analytical methods used in QC as well as the transfer and validation of methods to contract testing laboratories
  • Manage training of other analysts to perform laboratory procedures and assays
  • Participate in internal assessments and audits as required
  • Manage stability program
  • Serve as Quality Control representative during cross-functional/project meetings
  • Serve as subject matter expert between Quality Control and other departments, vendors, or contractors
  • Behave as a working backup QC analyst for testing activities as needed
  • Support Quality Systems such as Change Control, Deviation, CAPA, Audits, Quality Metrics
  • Manage and grow a phase appropriate team of Quality Control personnel
  • Establish user requirements for purchase of new Cellares GMP lab equipment
  • Manage equipment validation, calibration, maintenance, and troubleshooting
  • Assemble and report contract laboratory testing data
  • Assist in the preparation of dossiers and data packages in support of Cellares products for regulatory agencies
  • Other duties as assigned

51-200 employees

Cell therapy solutions