Senior Manager, Clinical Operations Quality Assurance - Remote

Overview

This role focuses on leading clinical quality assurance efforts at Baxter, ensuring compliance with regulatory standards and driving process improvements across clinical trials for pharmaceuticals and medical devices.

In Short

• Lead clinical quality assurance strategies and compliance efforts.
• Anticipate regulatory changes and ensure adherence to industry best practices.
• Provide clinical quality leadership and expertise to Clinical Operations.
• Review and approve quality assurance activities related to human subjects research.
• Conduct audits of clinical trials and operations.
• Manage quality metrics and risk assessments.
• Drive continuous process improvements in clinical quality.
• Collaborate with cross-functional teams to ensure high-quality clinical data.
• Stay updated on quality legislation and compliance standards.
• Travel to regulatory agencies and industry conferences as needed.

Requirements

• Bachelor's degree in a life science or related field.
• 5-7 years of experience in clinical quality assurance or regulatory affairs.
• Experience managing clinical quality assurance teams.
• Knowledge of clinical regulations and quality management systems.
• Strong leadership and communication skills.
• Ability to analyze complex data.
• Experience in Phase 0-IV clinical trials.
• Familiarity with GCP and GMP audits is a plus.
• Experience with clinical data management systems.
• Ability to work independently and drive strategies.

Benefits

• Comprehensive medical and dental coverage starting on day one.
• 401(k) Retirement Savings Plan with company matching.
• Employee Stock Purchase Plan (ESPP) at a discount.
• Paid time off ranging from 20 to 35 days based on service length.
• Flexible Spending Accounts and educational assistance programs.
• Paid parental leave and family medical leave options.
• Commuting benefits and childcare support.
• Employee Assistance Program (EAP).
• Competitive compensation and bonus eligibility.
• Support for reasonable accommodations for individuals with disabilities.