IT Regulatory Quality Assurance Manager (Hybrid)

Role Summary

The IT Regulatory Quality Manager is a key member of the Software Quality Assurance (SQA) team, responsible for ensuring IT operations and software lifecycle processes fully comply with regulatory requirements and corporate standards. This role requires strategic leadership in defining, implementing, and optimizing quality systems, and involves direct collaboration with cross-functional teams, business stakeholders, and the BTS Quality organization. The IT Regulatory Quality Manager will provide oversight of quality activities, especially across Mergers & Acquisitions (M&A), drive improvement initiatives, troubleshoot IT quality issues, and support all phases of the IT solution lifecycle. The incumbent acts as the primary point of contact between business units and quality teams, ensuring mutual understanding of needs and maintaining effective service agreements.

Responsibilities

• Develop, implement, and champion solution/change strategies that align with organizational objectives and evolving regulatory requirements.
• Lead continuous improvement initiatives, including enhancing quality assurance frameworks and promoting adoption of automation and advanced validation tools (e.g., pipelines, artificial intelligence).
• Monitor and proactively respond to changes in regulatory standards and industry best practices by updating SLC procedures and compliance processes.
• Serve as the primary SQA representative in strategic forums, steering committees, and regulatory engagements. Clearly communicate quality outcomes, audit results, and recommended improvements to partners and stakeholders.
• Support and manage regulatory audits and inspections, including preparing formal responses and overseeing remediation activities (CAPA implementation).
• Provide expert guidance and mentorship to cross-functional colleagues about computerized system quality practices, process optimization, and policy interpretation.
• Foster a culture of professional development by leading training initiatives, facilitating knowledge-sharing sessions, and supporting onboarding on Quality Assurance policies and practices.
• Oversee proper documentation and evidence management processes to maintain compliance and facilitate SQA investigations, CAPA activities, and audit readiness.
• Act as deputy for the Center of Excellence (CoE) leadership as needed by managing SLC communications, curating newsletters, coordinating meetings, and maintaining the SLC SharePoint site.
• Serve as a key escalation point for significant quality exceptions, risks, and issues, coordinating investigations and resolutions with minimal supervision.
• Participate in infrastructure change management and risk review activities across multiple sites, including governance meetings and timely risk assessment submissions to preserve compliance and business continuity.
• Develop, monitor, and interpret SQA metrics and trends, utilizing data-driven approaches to identify quality gaps and prioritize improvements; prepare executive-ready dashboards and reports for senior leadership.
• Lead and perform due diligence for quality and compliance during mergers and acquisitions, ensuring all regulatory requirements and best practices are upheld.
• Provide expert oversight for M&A activities, including assessment of acquisition documentation, management of systems/applications disposition, migration, or decommissioning, and guidance for compliant integration.
• Collaborate across functions to monitor M&A integration, address compliance issues, and act as liaison with leadership teams, support functions, and regulatory authorities.
• Create and deliver training and comprehensive reports to educate teams and inform executive stakeholders about identified risks, quality findings, and recommended actions.

Qualifications

• Bachelor’s degree with minimum 7 years’ relevant experience, or Master’s degree with minimum 6 years’ experience, including at least 2 years of supervisory responsibility.
• Proven experience managing relationships with Managed Service Providers (MSP) and directing outsourced validation or SLC activities.
• Experience leading DevOps and Agile projects and hands on experience with DevOps toolset.
• Demonstrated analytical skills, sound judgment, consultative capability, and strong communication proficiency, with the ability to influence and work effectively across diverse teams.
• Proficiency in automated pipeline technologies and advanced validation techniques.
• Deep understanding of software quality assurance and regulatory compliance requirements, including relevant industry standards and best practices.
• Experience in risk management, complex project oversight, and juggling multiple priorities in a dynamic environment.
• Direct experience supporting FDA and other regulatory agency inspections and interactions.
• Established project management experience, including training development and creation of knowledge materials.
• Ability to coach teams in policy, SLC execution, and regulatory requirements.
• Advanced knowledge of Computer Software Assurance (CSA) methodologies, data integrity, and contemporary validation practices.
• Professional certifications such as ASQ Certified Quality Auditor, Project Management Professional (PMP), Six Sigma, or equivalent.