Program Manager - Clinical Quality Assurance - Remote

Overview

The Program Manager - Clinical Quality Assurance is primarily responsible for leading the management of GCP quality activities in support of studies and projects across one or more clinical programs to drive proactive quality management, and ensure compliance with corporate policies and functional procedures and applicable global regulations.

In Short

• Develop and manage project timelines and deliverables for the RDQA Comprehensive Quality Strategy plan.
• Assess the success and effectiveness of the quality system and assure inspection readiness.
• Interpret and apply governmental regulations to study protocols.
• Interact with Development Operations to ensure quality compliance.
• Identify and mitigate potential clinical quality risks.
• Lead the effort to present an integrated quality strategy plan.
• Identify and implement fit-for-purpose quality management.
• Serve as the primary program quality liaison during health authority inspections.

Requirements

• Bachelor’s degree in a physical or life science, nursing, pharmacy, or equivalent experience.
• 5+ years of pharmaceutical industry experience in GCP quality assurance or related fields.
• 1+ years of GCP QA auditing experience preferred.
• Strong leadership and problem-solving abilities.
• Demonstrated ability in strategic planning and execution.
• Comprehensive knowledge of global Pharma and regulatory environments.

Benefits

• Comprehensive benefits package including paid time off.
• Medical/dental/vision insurance.
• 401(k) plan for eligible employees.
• Participation in short-term and long-term incentive programs.