Digital Quality & GxP Manager

Overview

Support Quality at Care Access and parent company Reify Health by managing compliance risk and providing practical guidance on GxP quality across the software product lifecycle, for both internal and external software, systems and AI products.

What you'll do

• Review and approve validation of software and AI products to ensure full compliance with regulatory requirements and company policies.
• Prepare for and support external regulatory audits; lead internal or vendor audits related to maintaining GxP and regulatory compliance.
• Develop and maintain digital/software components of quality management systems, including AI quality management systems.
• Proactively monitor systems and processes to ensure compliance with standard operating procedures, audit compliance 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.
• Build and maintain collaborative relationships with internal and external stakeholders to accomplish key business objectives across departments.

What you'll need

• 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 with the ability to effectively define business issues and recommendations.
• High attention to detail and organizational skills.
• Technical proficiency and understanding of data management in healthcare or clinical trial spaces.
• Highly detail-oriented with strong time management skills to manage multiple deadlines.
• Ability to work with minimal supervision and manage multiple priorities in a fast-paced environment.
• Minimum experience: 3+ years of experience implementing GxP standards and advising on matters of quality compliance at a SaaS company, including GxP systems validation.

Nice to have

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

Details

• Location: Remote within the United States; 100% of work performed in a remote office environment.
• Travel: Remote position with travel requirements up to 40%; occasional planned travel may be required.
• Physical demands: ability to use keyboards and other computer equipment.
• Care Access is unable to sponsor work visas at this time.