Quality Assurance Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the primary Quality Assurance liaison for the designated business unit, offering continuous QA support.

• Develop and implement quality strategies in collaboration with Operational and Strategic Quality Management teams.

• Lead quality enhancement initiatives and assist in achieving the quality objectives of the business unit.

• Assess and analyze quality performance while identifying opportunities for continuous improvement.

• Facilitate business development through RFIs, RFPs, quality agreements, and client quality documentation.

• Serve as the main QA contact for key clients and provide support for additional clients.

• Create and maintain quality policies, procedures, guidance documents, and training resources.

• Define and uphold site-specific regulatory requirements, quality records, business continuity plans, and compliance controls.

• Deliver training related to quality and advocate for quality objectives.

• Collaborate with project, product, and platform teams to integrate privacy, security, and regulatory requirements.

• Report on quality performance, audit results, compliance metrics, vendor audit metrics, and training metrics.

• Assist in internal and external inspections, audits, and regulatory engagements.

• Oversee system assessments and categorization activities for new products and initiatives.

• Provide QA support for platform maintenance, enhancements, documentation management, and long-term records retention.

⛳️ Requirements

• A Bachelor’s degree is required.

• 7 to 10 years of pertinent experience in quality assurance, quality management, or a related field within a regulated environment.

• In-depth knowledge of global GxP regulations and standards, including Good Clinical Practice (GCP), ICH E6, FDA regulations, and regional compliance requirements.

• Strong familiarity with clinical trial technologies, software solutions, and regulated product development environments.

• Experience in interpreting quality data, audit findings, investigations, and Corrective and Preventive Action (CAPA) activities.

• Understanding of privacy and security regulations, including GDPR, HIPAA, and associated compliance requirements.

• Ability to effectively collaborate within cross-functional teams while retaining ownership and accountability for deliverables.

• Strong business acumen and strategic thinking skills.

• Excellent organizational, interpersonal, verbal, and written communication abilities.

• Capacity to manage multiple priorities and meet established timelines and milestones.

• Experience in supporting regulatory inspections, audits, supplier oversight, and quality compliance activities on a global scale.

🏝️ Benefits

• Engaging work focused on quality that supports clinical research and enhances patient outcomes.

• Opportunity to advance clinical science and foster innovative technology.

• Collaborate with global teams.

• Contribute to life-changing therapies reaching patients more rapidly.