Associate Director, External Quality
2380 Conejo Spectrum St Suite 200, ION Thousand Oaks, CA 91320 US
Job Description
This role represents the company quality organization in the day to day monitoring of the GMP production and operations at contract manufacturing organizations, both commercial and clinical. Additionally, this role is responsible for quality metrics reporting, non-conformance, technology transfer, change control, and CAPA support.
The successful candidate is detail-orientated, proficient in communication (written and verbal), multitasks across multiple functional areas, is timeline focused and flexible in their work scheduling to meet the demands of a multi-product clinical phase cellular therapy company that is transitioning to the commercial phase.
Reports to: Associate Director/ Director, External Quality
Location: Thousand Oaks, CA
Primary Responsibilities:
- Partners with CMO to ensure compliant manufacture of products required for clinical supply, process validation and/or commercial supply.
- Collaborates with Manufacturing partners and internal cross functional teams to develop processes and systems that enable compliant, successful technology transfers, operation and lifecycle management of cGMP clinical and commercial manufacturing processes, ensuring product delivery schedules are met.
- Drives timely decisions and facilitates active communication and information flow between contract manufacturer and internal team members.
- Identifies and drives quality system process optimization initiatives and addresses opportunities for efficiency and capacity improvements.
- Collaborates with Manufacturing, Process Sciences, Supply Chain to support day to day GMP operations at the site
- Develops and fosters positive relationships with CMO Quality and Manufacturing leadership
- Advises on cross functional teams in problem solving and investigations that occur at the site
- Creates an inclusive environment and welcomes diversity
- Implements Quality requirements through review of documentation including batch records, deviations, CAPA, complaints, change controls and QC data in support of batch disposition
- Supports GMP inspections and audits from both regulatory authorities and collaborators
- Collaborates with QA colleagues to ensure integration of GMP batch disposition requirements between our company and CMOs
- Perform work that consistently requires independent decision making and the exercise of independent judgment and discretion
- Participate in Change Control, CAPA, and Deviation assessment and execution
- Follow up on CMO commitments to closure hold CMOs accountable
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in a manufacturing and office environment, with some warehouse environment work.
Travel: Some travel is required (25%)
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