Senior Manager, GxP – Digital Quality
CARE
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $110,000 - $145,000 per year
Job Level
About the role
- 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
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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GxP standardsGxP systems validationGood Clinical PracticeSaaS applicationagile product development methodologydata managementquality management systemsAI quality management systemsregulatory complianceaudit compliance
Soft Skills
leadershipcommunicationinterpersonal skillsanalytical skillsattention to detailorganizational skillstime managementability to work with minimal supervisionability to manage multiple prioritiesability to define business issues