Job Summary:
The Quality Assurance Manager is responsible for ensuring compliance with company policies, GCP regulations, and other relevant requirements. This role involves managing audits, document creation, CAPA management, and communication to meet quality objectives. The QA Manager reports to the Director of Quality.
Responsibilities:
- Write, revise, and review SOPs, policies, and quality documentation
- Provide guidance on non-conformance situations and investigations
- Communicate compliance requirements at all levels
- Represent the organization in quality-related presentations
- Support inspection readiness and host audits
- Develop quality systems to enhance compliance
- Implement quality management plans for projects
- Manage and host sponsor audits
- Maintain annual audit plans and regulatory knowledge
- Develop quality indicators and metrics
- Provide GCP training sessions
- Manage the electronic Quality Management System
- Schedule Service Provider Qualifications
- Oversee Computer System Validation and audits on projects
- Act as QA Representative on clinical studies
Qualifications:
- 2 to 3 years of ZenQMS administration experience
- 3 years of experience in CSV/Change Control Management
- 3 to 5 years of experience in hosting sponsor audits
- Experience in a CRO environment
- Bachelor''s or advanced degree in science or related field with 8+ years in Quality
Knowledge & Skills Requirements:
- Knowledge of FDA regulations, ICH-GCPs, and worldwide regulatory guidelines
- Ability to interact with sponsors, mentor, and manage audit findings
- Experience in developing quality systems and writing SOPs
- Familiarity with clinical development software and 21CFR Part 11
- Willingness to travel up to 25%
- CQA or RQAP-GxP Certification is a plus