Manager, Quality Control
800 Saginaw Drive Redwood City, CA 94063
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.