AG Mednet, Inc. · 5 hours ago
Quality & Regulatory Compliance
Boston, MA
Full-time
Onsite
Senior Level
$150K/yr - $180K/yr
7+ years expAG Mednet is a software platform company operating at the intersection of clinical trials, data integrity, and regulatory compliance, supporting life sciences customers worldwide. They are seeking a Quality & Regulatory Compliance (QRC) person to provide strategic leadership and oversight of their quality and regulatory programs, ensuring alignment with global regulations and standards relevant to the Life Science sector.
Clinical TrialsInformation TechnologyMedicalSoftware
Hiring Manager
Nicholas Tsekeris, aPHR
Responsibilities
Serve as a player-coach by combining hands-on ownership of quality, compliance, and regulatory activities with leadership and mentorship of the QRC team
Actively monitor regulatory and compliance developments, assess applicability to AG Mednet, and proactively advise leadership and cross-functional stakeholders
Maintain embedded quality and compliance oversight across the software development lifecycle, including validation strategy, change management, and release readiness and approval
Develop and implement sustainable systems and processes that support organizational growth while adhering to global regulations and standards
Establish streamlined procedures, metrics, and indicators to measure and continually enhance processes
Monitor the effectiveness of quality management and lead the management review process, reporting to senior leadership
Support commercial and customer-facing activities, including RFP/RFIs and client discussions, as a senior quality and regulatory representative
Manage and support customer audits and inspections, as needed, and oversee vendor compliance activities (e.g., tool qualification) to ensure alignment with customer regulatory requirements
Manage the CAPA / Quality Event program in collaboration with department managers
Create training plans and oversee the administration of the employee Training program
Collaborate with the Security Office to attain and maintain SOC 2 certification and enhance the company's security assurance program
Act as the company Privacy Officer, including developing and implementing privacy policies, procedures, and training, addressing privacy concerns, reviewing contracts related to privacy and data protection, investigating potential breaches, and cooperating with regulatory authorities
Maintain AG Mednet’s Privacy Shield certification and monitor the privacy regulatory landscape for relevance to AG Mednet
Qualification
Required
Bachelor's degree in a relevant field (Regulatory Affairs, Life Sciences, Computer Science, or similar) and/or 7-10+ years of relevant experience in quality, regulatory compliance, and/or risk management roles supporting cloud-hosted software or enterprise SaaS platforms within the pharmaceutical/biotech or life sciences industries
Demonstrated experience building and/or leading high performing QRC teams, and supporting individual member's professional growth
Profound knowledge of regulations and controls (e.g., 21 CFR Part 11, CSV, ICH GCP, HIPAA, GDPR, SOC 2)
Strong project management experience with a track record of successfully leading and completing quality and compliance improvement projects
Demonstrated ability to influence cross-functional stakeholders and communicate complex regulatory topics clearly and pragmatically
Excellent organizational, document management, and communication skills
Proficiency in prioritizing, managing, and delivering on multiple projects concurrently, coupled with a strong motivation to excel in a dynamic, fast-paced environment. A team player with a proactive problem-solving approach
Preferred
Familiarity with modern SaaS architectures and cloud environments
Experience with Atlassian products (Jira and Confluence), learning management system (LMS) and document management system (DMS) platforms
Company
AG Mednet, Inc.
Judi by AG Mednet empowers the doers, clinical trial leaders, and medical innovators, with streamlined process management software, allowing them to focus on what they do best, providing breakthrough treatments and products.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Doug Steinfeld
Chief Technology Officer
Brian Zabin
Chief Operating Officer
Company data provided by crunchbase