Quality Assurance Manager - San Diego, United States - Yomagroup

Description

About the job Quality Assurance Manager

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 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

Must Have
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

Nice-to-Have
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)

Key Competencies
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

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