Remote Digital Quality & GxP Manager

Care Access; United States; Remote; USD 110,000 - 140,000; Full time

Benefits offered by this job

PTO & Holidays

Medical / Dental / Vision

HSA / FSA

HSA employer contrib

Disability insurance

401(k) match

Job summary

Care Access seeks a Digital Quality & GxP Manager to join our Quality team and guide GxP quality across software products, AI components, and systems. You will lead compliance activities, align with regulatory expectations, and collaborate with multiple stakeholders in a fast-paced tech environment.

The role emphasizes hands-on GxP implementation, audits, and practical quality guidance for internal and external products. A remote US-based position with up to 40% travel is available.

Qualifications

• Certifications in GxP quality, CSV or quality systems management preferred.
• 3+ years implementing GxP standards and advising on SaaS quality compliance.
• Experience with software products in healthcare or clinical trials.

Responsibilities

• 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.
• Development and maintenance of 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.

Skills

Leadership experience

GCP experience

SaaS experience

Communication skills

Analytical skills

Attention to detail

Healthcare data

Time management

Multitasking

Education

GxP certifications

GxP experience

Job description

Care Access seeks a Digital Quality & GxP Manager to join our Quality team and guide GxP quality across software products, AI components, and systems. You will lead compliance activities, align with regulatory expectations, and collaborate with multiple stakeholders in a fast-paced tech environment.

The role emphasizes hands-on GxP implementation, audits, and practical quality guidance for internal and external products. A remote US-based position with up to 40% travel is available.