Clinical Software Quality Manager

Job Summary:

The Clinical Software Manager serves as the Quality representative to the Clinical organization, providing strategic guidance on software systems and data governance across all phases of clinical development. This role partners closely with internal & external clinical stakeholders to ensure compliant, risk-based oversight of software, digital tools, and Real-World Data environments, translating regulatory and quality requirements into clear, practical direction. The successful candidate combines strong software expertise, the ability to rapidly deepen clinical knowledge, and executive presence to inspire confidence and alignment in every interaction.

This role oversees the team members who perform assessment, qualification, and audit clinical, software, and pre-clinical vendors to ensure alignment with global regulatory requirements and internal quality standards. Working with team members, the role drives risk-based vendor oversight, corrective action, and continuous improvement to support compliant and innovative clinical initiatives.

Job Responsibilities:

• Serve as a trusted advisor to clinical stakeholders (internal & external), providing clear, confident direction on software quality, governance, and risk. Ensure stakeholders leave software discussions aligned, reassured, and confident in the path forward.
• Bring strong software expertise with the ability to develop deep understanding of clinical systems and Real-World Data environments. Building on foundational knowledge of software systems and software validation growing an understanding of software & data through all phases of Clinical.
• Communicate with executive presence and influence, building trust and alignment across cross-functional teams. Strong communication and interpersonal skills, capable of engaging cross-functional teams, resolving ambiguity, and influencing decisions as it is related to software or data quality.
• Lead the Clinical Software Quality team, including software auditors, driving accountability, high performance, and regulatory compliance. Manage the team that conducts periodic audits and qualification assessments for clinical, software, and pre-clinical vendors, verifying adherence to regulatory requirements (FDA, ISO 13485, IEC 60601, ISO 14155, 21 CFR Part 11, Computer Software Assurance) and company quality standards.
• Drive continuous improvement and audit readiness, strengthening vendor oversight, risk-based controls, and quality system integration.
• Lead, mentor, and develop the software auditing team, facilitating training programs and fostering a culture of collaboration and continuous improvement in audit and IT security practices.
• Promote effective communication regarding types of clinical vendors, audit findings, and how vendor software affects clinical studies and research outcomes.
• Support governance and corrective action management, ensuring that all issues are resolved in line with organizational and regulatory expectations.

Required Qualifications:

• Minimum bachelor’s degree in computer science, engineering, life sciences, or a related field; advanced degrees preferred.
• Minimum of 5 years of experience in software quality, validation, audit, or quality systems within a regulated industry (e.g., medical devices, pharmaceuticals, life sciences).
• Proven background in ISO 13485, IEC 60601, FDA guidelines, ISO 14155, and 21 CFR Part 11.
• Minimum of 3 years’ experience in a managerial or leadership role within clinical, auditing, quality assurance, or regulatory compliance.
• Proven ability to lead, mentor, and develop teams, fostering collaboration and continuous improvement.

Preferred Qualifications:

• Advanced experience in software quality, validation, or audit within a regulated environment (e.g., FDA, ISO 13485, GxP), with demonstrated understanding of risk-based approaches such as CSA and data integrity principles.
• Proven expertise in clinical systems, Real-World Data/Evidence, or Digital Health Technologies, including vendor oversight and governance of externally hosted platforms.
• Strong executive communication and stakeholder engagement skills, with experience influencing cross-functional teams and providing clear, defensible quality guidance at senior organizational levels.