Manager, Quality Control

Redwood City, CA 94063

Posted: 04/20/2020 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 17409

Job Description


Manager, Quality Control

Core Duties and Responsibilities:

 

Approximately 2-3 direct reports

 
  • Review executed QC test records for product release, including the investigation and resolution of deviations, OOS and OOT observations.
  • Perform routine QC testing as needed
  • Serve as a QC subject matter expert on various methods within the CMC team and with external partners (CMO’ s and CTL’ s)
  • Plan, organize and coordinate the activities related to QC Analytical and Stability testing to ensure timely completion of tasks
  • Write, organize and review QC analytical result tables, protocols and reports.
  • Works in conjunction with other Assay development to qualify, validate and transfer QC analytical methods as applicable
  • Participate in continuous improvements of quality systems (procedures and systems) to improve organization effectiveness, quality assurance compliance, and regulatory and other requirements
  • Assist in Quality Metric review processes, assess data for adverse trends, develop solutions and oversee implementation.
  • Authors and Reviews CMC regulatory submissions
  • Works with QC management and project team lead to identify and mitigate risks to meeting QC milestones and goals.
  • Coordinate with the Quality Assurance Department for required review and approval of documents
  • Responsible for development of direct reports
  • Responsible for training of QC staff

 

 

Position Requirements and Experience:

 
  • 5 to 7 years in a GMP environment (pharmaceutical or biotechnology industry) with at least 3 years in QC management role or equivalent
  • CMO management and oversight, working with outside vendors.
  • Solid knowledge and understanding of US and international regulations and guidance applicable to Quality Control and method validation
  • Experience in quality control required.  A strong background in molecular biology is desired.
  • Experience transferring assays from Assay Development to Quality Control is required.
  • Experience in assay qualification and validation strongly desired. Experience with  viral  vector (adeno-associated virus) product is a plus.
  • Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries required. Must have laboratory experience with a variety of analytical techniques including, but not limited to, quantitative PCR, ELISA, and cell-based methods.
  • Knowledge of statistical methods applicable to the analysis of data.
  • Proficient in general and non-routine laboratory skills.
  • Experience working with contract testing labs.
  • Excellent interpersonal, communication and organizational skills.
  • Ability to make sound decisions about team activity scheduling, allocation of resources, and priorities.
  • Flexibility in  problem solving, providing direction and work hours to meet business objectives. Good oral and written communication skills. MS Office skills; equipment related software such as  Soft Max  Pro desired.

 

 

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Ron Tess

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