Associate Director, Quality Operations
$160,000–$230,000 year
Remote · San Diego, California, United States
Job Summary
Associate Director, Quality Operations responsible for overseeing quality programs to support product realization and inspection readiness across GxP activities. Leads vendor assessment and qualification, vendor inspection readiness, CAPA and audits, QA release of batches, deviation and CAPA management, risk management, documentation library development, and cross-functional communications with stakeholders. Requires 10+ years in quality systems, GxP experience in pharma/biologics, audit experience, ability to manage multiple workstreams, willingness to travel up to 20%, and a degree in a science field.
Required Qualifications
- Degree in any science related discipline
- Minimum 10 years of experience in quality system implementation and/or execution of quality events across various pharmaceuticals or biologics
- Minimum 6 years of experience in GxP service provision including management of various workstreams and/or customers
- Previous experience with management of quality assurance and quality control systems including laboratories, document management and quality event management
- Knowledge of GxP operations for clean rooms, facilities, and associated equipment
- Ability to work in a dynamic environment with a high degree of flexibility
- Previous audit experience
- Strong critical thinking skills and ability to apply sound judgment and decision making based on risk and phase of development
- Ability to manage multiple workstreams across multiple disciplines
- Up to 20% of domestic and international travel required
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