77 Quality Assurance Manager Jobs in San Diego, CA
Torrey Pines Solutions is Hiring a Quality Assurance Manager Near San Diego, CA
Quality Assurance Manager
Job Description
General Purpose
The primary responsibility of this position is to oversight GxP activities and maintain the effective quality system within the company. This position will report directly to CEO and work closely with our CMC and Clinical Operations teams to ensure the compliance of relevant regulatory. The duties include but not limited to maintain appropriate document system, review/approve critical documents and perform the audit internally or externally.
Main Job Tasks and Responsibilities
- Responsible for QAU administration.
- Torrey Pines Solutions is Hiring! We have an immediate need for a Quality Manager. Candidate must have Biotech/Pharma industry GxP experience - No exceptions. Principals only no agencies. For immediate consideration, please contact me at rwilliamson@torreypinessolutions or reviewing required documents for G M P compliance.
- The maintenance of the document management system.
- Identify training needs and organize training interventions to meet quality standards
- Perform the internal/external audit and finalize the audit report
- Evaluate audit findings and ensure appropriate corrective as well as preventive actions in place if applicable
- Cooperate with internal team/external parties to investigate customer complaints and non-conformance issues
- Analyze data to identify areas for improvement in the quality system
- Additional duties as required and assigned
- B.S. or M.S. in sciences
- Prior experience as a QA Auditor
- Auditing experience of GMP quality standards
- Ability to analyze and sort problems in a logical way with root cause analyses of non-compliance and CAPA
- Working experience with CMO/CRO/Outsourcing Testing Lab (OTL)
- Drug substance/product or pharmaceutical industry-specific experience
- Certifications an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma
- Auditing experience of GCP quality standards
- Experience with implementation of corrective/preventive action programs
- Knowledge of relevant regulatory requirements (FDA GxP regulations and ICH guidelines)
- attention to detail
- communication skills - verbal and written
- data collection, management and analysis
- problem analysis and problem solving
- planning and organizing
- judgment
- decision-making
- teamwork
Job Summary
Full Time
$114k-143k (estimate)
04/22/2024
05/08/2024
The following is the career advancement route for Quality Assurance Manager positions, which can be used as a reference in future career path planning. As a Quality Assurance Manager, it can be promoted into senior positions as a Quality Assurance Senior Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Assurance Manager. You can explore the career advancement for a Quality Assurance Manager below and select your interested title to get hiring information.
