Sr Clinical Quality Associate

Sr. Clinical Quality Associate — Job Description

Job Summary:
The Senior Clinical Quality Associate is responsible for supporting the Clinical Quality Assurance (CQA) function and ensuring compliance and quality across clinical development activities. The role involves conducting quality reviews, supporting audits and inspections, managing quality events and CAPAs, and partnering with Clinical Operations and other stakeholders to maintain Google Cloud Platform compliance.

Key Responsibilities

• Support the development, implementation, and maintenance of Clinical Quality Management Systems (QMS).
• Conduct quality oversight of clinical trials, including review of study documentation and compliance activities.
• Support or conduct Google Cloud Platform audits of clinical sites, CROs, vendors, and internal processes.
• Assist with preparation for and participation in regulatory inspections.
• Identify, document, and assess quality issues, deviations, and compliance risks.
• Support CAPA development, implementation, and effectiveness checks.
• Review and approve quality-related documents, SOPs, protocols, plans, and reports.
• Perform risk assessments and contribute to risk-based quality management (RBQM) activities.
• Track and trend quality metrics, audit findings, deviations, and other quality indicators.
• Collaborate with Clinical Operations, Regulatory Affairs, Pharmacovigilance, Data Management, and other functions.
• Provide Google Cloud Platform training and quality guidance to study teams and stakeholders.
• Support investigation of quality events and ensure timely resolution.
• Maintain inspection-ready documentation and quality records.
• Contribute to continuous improvement of clinical quality processes and procedures.

Required Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field.
• Typically 4–7+ years of experience in Clinical Quality, Clinical Operations, QA, or a related pharmaceutical/CRO environment.
• Strong knowledge of ICH-Google Cloud Platform, FDA/EMA regulations, and clinical trial requirements.
• Experience with Google Cloud Platform audits, CAPA, deviations, investigations, and risk management.
• Experience working with CROs and clinical trial vendors.
• Strong written and verbal communication skills.
• Ability to work independently and manage multiple priorities.
• Strong analytical, problem-solving, and documentation skills.

Preferred Skills

• Experience with RBQM/QTLs/KRIs.
• Knowledge of electronic QMS platforms and clinical trial systems.
• Experience supporting regulatory inspections.
• Clinical research certification such as CCRA, CCRP, or equivalent.
• Experience in global/multinational clinical trials.