Digital Quality Manager – GxP

This is a fully remote position, open to applicants in United States.

📋 Description

• Evaluate and authorize the validation of software and AI products to guarantee complete adherence to regulatory standards and company policies.

• Prepare for and facilitate external regulatory audits.

• Oversee internal or vendor audits concerning the maintenance of GxP and regulatory adherence.

• Create and sustain digital/software elements of quality management systems, including those specific to AI.

• Actively monitor systems and processes to ensure compliance with standard operating procedures, audit standards, and industry best practices.

• Assess key vendors for conformity with digital quality standards.

• Educate and train internal stakeholders on quality methodologies and best practices.

• Execute additional tasks and special projects as designated by quality leadership.

• Establish and nurture collaborative relationships with both internal and external stakeholders across various departments.

• Travel up to 40% as necessary.

⛳️ Requirements

• Proven leadership experience in the implementation of compliance programs within the software industry.

• Experience with Good Clinical Practice is mandatory.

• Demonstrated expertise in SaaS applications and agile product development methodologies.

• Exceptional communication and interpersonal abilities.

• Strong analytical capabilities with a knack for clearly defining business challenges and proposing recommendations.

• High attention to detail along with excellent organizational skills.

• Technical knowledge and comprehension of data management in healthcare or clinical trial environments.

• Highly detail-oriented with robust time management skills to juggle multiple deadlines.

• Capacity to work independently and manage various priorities in a fast-paced setting.

• A minimum of 3 years of experience implementing GxP standards and advising on quality compliance issues within a SaaS company, including GxP systems validation.

• Preferred certifications in GxP quality, computer systems validation processes, or quality systems management.

• Must be eligible to work remotely within the United States.

• Care Access is currently unable to sponsor work visas.

🏝️ Benefits

• Paid Time Off (PTO) and 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.