Senior Manager, Clinical Quality Assurance (CQA)

The Senior Manager, Clinical Quality Assurance (CQA) is responsible for ensuring that clinical trials are conducted in accordance with applicable regulatory requirements, company SOPs, and industry standards. This individual will lead and support GCP QA activities including audits, inspection readiness, and quality oversight of clinical development programs.

Requirements

• Bachelor’s or advanced degree in life sciences, pharmacy, nursing, or a related field
• Minimum 8+ years of relevant experience in Clinical Quality Assurance, including 3+ years in a leadership or managerial role
• In-depth knowledge of ICH-GCP, E6-R3 guidelines, FDA, EMA and other relevant international regulatory requirements
• Experience conducting clinical site, vendor, and system audits
• Proven experience in inspection readiness and participation in regulatory inspections
• Strong project management, problem-solving, and interpersonal skills
• Ability to work independently in a fast-paced, matrixed environment
• Excellent communication and writing skills

Benefits

• Employee relocation sponsored
• Equal employment opportunities
• Non-discrimination policy