Senior Manager, GxP & Digital Quality
About The Position
We are seeking a Senior Manager, GxP and Digital Quality to join our Quality team and help to support Quality at Care Access and our parent company Reify Health. This role will help to manage compliance risk and provide practical guidance on GxP quality at all stages of the software product lifecycle. The successful candidate will have hands-on experience implementing GxP compliance at a fast-paced technology company and will support quality for both internal and external software products, systems and AI products. The Senior Manager, GxP and Digital Quality must build and maintain collaborative relationships with internal and external stakeholders to accomplish key business objectives across departments.
Requirements
- 3+ years of experience implementing GxP standards and advising on matters of quality compliance at a SaaS company, including GxP systems validation
- Demonstrated leadership experience in implementing compliance programs within the software industry. Project management experience preferred.
- Experience with Good Clinical Practice is required
- 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
Nice To Haves
- Certifications in GxP quality, computer systems validation processes or quality systems management preferred.
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
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
