Digital Quality & GxP Manager

For our client, we are seeking a Digital Quality & GxP Manager to join the team of a leader in the Healthcare space.
This role will own the quality and compliance oversight for digital and software-based products in a regulated healthcare environment. You will partner closely with internal stakeholders and external vendors to ensure GxP standards are met across validation, audits, documentation, and ongoing system use. The position requires strong coordination across quality, technical, and operational teams to maintain robust controls and support inspection readiness.
Location: Remote
Compensation: $110,000 – $140,000 annually
Responsibilities
Review and approve software and AI product validation for compliance
Prepare for and support external regulatory audits
Lead internal and vendor audits for GxP compliance
Develop and maintain quality management systems for digital and software solutions
Monitor systems to ensure compliance with standard operating procedures
Review vendor compliance with digital quality requirements
Train internal stakeholders on quality processes
Qualifications
5-7 years of leadership experience in compliance programs within the software industry
Proven experience with Good Clinical Practice (GCP)
Familiarity with SaaS applications and agile product development
Strong communication and interpersonal skills
Excellent analytical skills for defining business issues
High attention to detail and strong organizational skills
Technical proficiency in data management in healthcare or clinical trial settings
Benefits
Paid Time Off (PTO) and company-paid holidays
100% employer-paid medical, dental, and vision insurance
Health Savings Account and Flexible Spending Accounts
Bi-weekly HSA employer contribution
Company-paid Short-Term and Long-Term Disability
401(k) Retirement Plan with company match
Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.