Head of Quality & Regulatory Compliance

AG MEDNET INC•Boston, MA

32m

About The Position

Overview: AG Mednet is a software platform company operating at the intersection of clinical trials, data integrity, and regulatory compliance, supporting life sciences customers worldwide. We are seeking a Head of Quality & Regulatory Compliance (QRC) to provide strategic leadership and oversight of our quality and regulatory programs. The QRC function plays a pivotal role in ensuring that AG Mednet's products and services align with global regulations and standards relevant to the Life Science sector (e.g., 21 CFR Part 11, Computer System Validation, ICH GCP, HIPAA, GDPR, etc.), as well as safeguarding data through appropriate controls (SOC 2, NIST, ISO/IEC 27000 series standards, etc.). Position Summary: The Head of QRC is a senior leadership role responsible for owning and scaling AG Mednet’s Quality Management System (QMS) and regulatory compliance strategy across our cloud-based SaaS products and services. The ideal candidate brings deep experience supporting regulated B2B SaaS platform development and delivery and proactively translates regulatory and compliance requirements into practical, risk-based guidance that enables product innovation and business growth.

Requirements

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.

Nice To Haves

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

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.