Overview
Manager of Quality Assurance Jobs in United States at CIMS Global
Title: Manager of Quality Assurance
Company: CIMS Global
Location: United States
Job description
The Quality Assurance (QA) Manager is responsible for establishing, implementing, and maintaining the Quality Management System (QMS) to ensure that all clinical data services are conducted in compliance with applicable regulatory requirements, industry standards, client expectations, and company Standard Operating Procedures (SOPs).
The QA Manager oversees quality activities across Data Management, Biostatistics, Statistical Programming, Medical Writing, Clinical Data Standards, Validation, and related biometrics functions. This role leads internal audits, vendor qualification, CAPA management, inspection readiness, and continuous quality improvement initiatives while promoting a culture of quality throughout the organization.
Responsibilities
Quality Management System (QMS)
- Develop, implement, maintain, and continuously improve the company's QMS.
- Create, review, approve, and maintain SOPs, work instructions, templates, and quality guidelines.
- Ensure compliance with ICH E6(R3), GCP, 21 CFR Part 11, GDPR, HIPAA, ALCOA+, and applicable regulatory requirements.
- Manage document control and change control processes.
Quality Oversight
- Establish quality metrics and Key Performance Indicators (KPIs) across biometrics functions.
- Monitor quality trends and identify opportunities for process improvements.
- Review project quality metrics and ensure timely resolution of quality issues.
- Lead continuous improvement initiatives.
Audit Management
- Plan and conduct internal quality audits.
- Coordinate sponsor audits and regulatory inspections.
- Perform vendor qualification and periodic vendor audits.
- Prepare audit reports and track findings through closure.
CAPA Management
- Lead investigation of quality issues and non-conformances.
- Perform root cause analyses.
- Develop and monitor Corrective and Preventive Action (CAPA) plans.
- Verify CAPA effectiveness.
Clinical Data Services Oversight
Provide QA oversight for:
- Clinical Data Management
- Database Design
- Data Validation
- Medical Coding
- Statistical Programming (SAS/R)
- Biostatistics
- SDTM/ADaM Development
- TLF Production
- CSR Statistical Reporting
- Data Review
- Database Lock Activities
- Regulatory Submission Deliverables
Computer System Validation (CSV)
- Review validation documentation for computerized systems.
- Ensure validated status of GxP systems.
- Participate in IQ/OQ/PQ reviews.
- Review validation protocols and reports.
AI & Technology Governance (Preferred)
- Participate in governance of AI-enabled biometrics workflows.
- Review validation documentation for AI/ML applications.
- Ensure appropriate Human-in-the-Loop (HITL) controls.
- Support validation of cloud-based analytics environments.
Training
- Develop quality training programs.
- Conduct GCP, SOP, CSV, and quality training.
- Monitor training compliance.
Inspection Readiness
- Maintain inspection readiness across the organization.
- Support sponsor due diligence activities.
- Coordinate responses to audit observations.
Education
· Bachelor’s degree in life sciences, health sciences, information technology, or related field.
· MSc in life science, medicine, or related field is a plus.
Experience
· Minimum of 3 years of relevant experience in a similar role clinical research or CRO environments.
· Experience supporting biometrics functions is strongly preferred.
· Experience with sponsor audits and regulatory inspections.
· Experience implementing Quality Management Systems.
Skills and Competencies
· Strong knowledge of clinical trial processes, ICH-GCP, and regulatory requirements
· Strong analytical, problem-solving, and training skills.
· Attention to detail and ability to manage multiple projects simultaneously.
· Effective communication and interpersonal skills for cross-functional collaboration.
· Familiarity with regulatory inspection requirements and audit processes.
