Manager of Quality Assurance

Role Overview

The Quality Assurance Manager is tasked with building, operating, and refining the Quality Management System so that clinical data services consistently meet regulatory obligations, industry expectations, client requirements, and internal SOPs. This position provides quality oversight for biometrics-related activities, including data management, biostatistics, statistical programming, medical writing, clinical data standards, validation, and other connected functions.

Quality Management System

• Create, implement, maintain, and continually strengthen the organization’s QMS.
• Draft, revise, approve, and control SOPs, work instructions, templates, and quality standards.
• Ensure adherence to ICH E6(R3), GCP, 21 CFR Part 11, GDPR, HIPAA, ALCOA+, and other applicable regulations.
• Administer document control and change control workflows.

Quality Oversight

• Define quality metrics and KPIs across biometrics functions.
• Track quality trends and identify process improvement opportunities.
• Evaluate project-level quality indicators and drive prompt issue resolution.
• Champion ongoing improvement efforts across the business.

Audit Management

• Schedule and carry out internal quality audits.
• Support sponsor audits and regulatory inspections.
• Complete vendor qualification activities and periodic vendor audits.
• Document audit outcomes and follow findings through closure.

CAPA Management

• Investigate quality incidents and non-conformances.
• Perform root-cause analysis to identify underlying issues.
• Create, monitor, and maintain CAPA plans.
• Check and confirm the effectiveness of corrective and preventive actions.

Clinical Data Services Oversight

• Provide QA oversight for clinical data management, database design, data validation, medical coding, statistical programming, biostatistics, SDTM/ADaM development, TLF production, CSR statistical reporting, data review, database lock activities, and regulatory submission deliverables.

Computer System Validation

• Review validation records for computerized systems.
• Confirm that GxP systems remain in a validated state.
• Take part in IQ, OQ, and PQ reviews.
• Assess validation protocols and final reports.

AI and Technology Governance

• Contribute to governance for AI-enabled biometrics workflows.
• Review validation evidence for AI/ML tools and applications.
• Ensure suitable Human-in-the-Loop controls are in place.
• Support validation efforts for cloud-based analytics environments.

Training

• Design quality-focused training programs.
• Deliver training on GCP, SOPs, CSV, and quality topics.
• Track and improve training compliance.

Inspection Readiness

• Keep the organization prepared for inspections at all times.
• Assist with sponsor due diligence reviews.
• Coordinate responses to audit observations.

Education

A bachelor’s degree in life sciences, health sciences, information technology, or a related discipline is required. A master’s degree in life science, medicine, or a related field is considered an added advantage.

Experience

At least 3 years of relevant experience in a similar position within clinical research or CRO settings is required. Experience supporting biometrics functions is strongly preferred, along with exposure to sponsor audits, regulatory inspections, and the implementation of Quality Management Systems.

Skills and Competencies

The ideal candidate should have a strong grasp of clinical trial processes, ICH-GCP, and regulatory expectations. Excellent analytical and problem-solving ability, strong training skills, attention to detail, cross-functional communication, interpersonal effectiveness, and the ability to manage several priorities at once are important for success in this role.