Digital Quality & GxP Manager

The role

The Digital Quality & GxP Manager manages compliance risk and provides guidance on GxP quality across the software product lifecycle. This role supports quality for internal and external software, systems, and AI products.

What you will do

• Review and approve validation of software and AI products
• Prepare for and support external regulatory audits
• Lead internal or vendor audits related to GxP and regulatory compliance
• Develop and maintain digital and software components of quality management systems
• Monitor systems and processes to ensure compliance with SOPs and industry best practices
• Review key vendors for compliance with digital quality requirements
• Train and educate internal stakeholders on quality processes and best practices
• Perform other tasks and special projects assigned by quality leadership

Required qualifications

• Demonstrated leadership experience in implementing compliance programs within the software industry
• Experience with Good Clinical Practice
• Demonstrated experience with SaaS application and agile product development methodology
• Excellent communication and interpersonal skills
• Strong analytical skills
• High attention to detail and organizational skills
• Technical proficiency and understanding of data management in healthcare or clinical trial spaces
• Ability to work with minimal supervision and manage multiple priorities in a fast-paced environment
• 3+ years of experience implementing GxP standards and advising on matters of quality compliance at a SaaS company, including GxP systems validation
• Ability to use keyboards and other computer equipment

Nice to have

• Project management experience
• Certifications in GxP quality, computer systems validation processes or quality systems management

Benefits

• Paid Time Off (PTO)
• Company Paid Holidays
• 100% Employer paid medical, dental, and vision insurance plan options
• Health Savings Account and Flexible Spending Accounts
• Bi-weekly HSA employer contribution
• Company paid Short-Term Disability and Long-Term Disability
• 401(k) Retirement Plan, with Company Match

Before you apply

• Care Access is unable to sponsor work visas at this time
• Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment

About the company

Care Access works to make the future of health better for all through research locations, mobile clinics, and clinicians. They aim to bring world-class research and health services directly to communities that face barriers to care.