• Oversee high-priority compliance inspections and reports • Manage a team of 15 to 20 individuals performing inspection deliverables • Transform inspection data into litigation-ready reports • Ensure 100% evidentiary integrity through refined review protocols • Apply a litigation-informed lens to documentation to eliminate reporting vulnerabilities • Standardize interview methodologies to reduce remediation cycles • Synthesize data into high-level risk insight reports with actionable recommendations • Lead the review and validation of inspection reports • Identify inconsistencies across inspection activities and guide corrective action • Coach inspection teams on compliance and evidentiary proof.

• Conduct regular monitoring activities to ensure business operations comply with applicable laws, regulations, and internal policies • Review and analyze transactions, reports, and other documents to identify potential compliance issues • Assist in the development and implementation of monitoring plans such as daily, weekly, monthly, and/or quarterly checks • Prepare detailed reports of monitoring activities and findings • Communicate findings to the Compliance Assurance Monitoring Manager and other relevant stakeholders • Assist in the preparation of regulatory filings and reports as required • Assist in the review and updating of internal controls, policies, and procedures to ensure they remain current and effective • Provide recommendations for improvements based on monitoring activities and regulatory changes • Participate in the development and delivery of compliance training programs for employees • Promote a culture of compliance and awareness throughout the organization • Support investigations into potential compliance breaches or irregularities • Assist in developing and implementing corrective action plans to address identified issues • Work closely with other departments (e.g. Legal, Finance, Operations) to ensure a coordinated approach to compliance • Liaise with external regulators and auditors as needed • Stay informed about industry trends, regulatory updates, and best practices in compliance monitoring • Contribute to continuous improvement initiatives within the Compliance Assurance team.

• Serve as the dedicated IT business partner for the Quality organization; develop a deep understanding of QA processes, priorities, and roadmap to anticipate and address IT needs proactively • Own Veeva Vault Quality (QualityDocs and associated modules) as the IT system owner: manage system configuration, user administration, release management, and enhancement delivery in partnership with QA stakeholders • Translate Quality business requirements into system enhancements, workflow changes, and configuration updates; manage the enhancement backlog and release cycle in coordination with QA and vendors • Advise Quality on system risk, compliant use of technology, and IT implications of process changes; serve as a trusted technical advisor on how systems can best support quality operations • Participate in QA planning meetings and strategic initiatives to ensure IT capabilities and constraints are represented from the outset • Author validation scripts, test protocols, and supporting documentation (IQ/OQ/PQ) for GxP-regulated systems including Veeva Vault, SAS Validated Cloud, Egnyte GxP, and validated MuleSoft integrations; partner with QA for CSV review and approval • Assess system changes for validation impact; manage change control documentation and ensure validated systems are maintained in a compliant state following changes • Conduct and document periodic reviews of validated systems; manage decommissioning procedures in line with regulatory requirements • Own IT inspection readiness across the validated systems portfolio. • Partner with QA to ensure IT systems and electronic records meet 21 CFR Part 11 and other regulatory requirements; lead IT response to inspection findings and drive remediation to closure • Maintain audit-ready evidence packages for GxP systems: audit trail integrity, access control records, system configuration documentation, and change history • Own the IT policy library: author, version, and maintain SOPs and policies covering electronic records, audit trails, access control, change management, data classification, and AI use • Develop and deliver IT compliance training; maintain training records in validated learning management infrastructure • Manage the IT third-party risk management program: vendor tiering, GxP qualification assessments, data handling reviews, and ongoing oversight for technology suppliers and SaaS providers. • Evaluate new technology and AI vendors against Apogee’s governance framework prior to onboarding; coordinate security assessment inputs with the Director of Cybersecurity

• Support day-to-day PECOS filings, vendor regulatory documentation, and provider credentialing activities. • Prepare and submit PECOS enrollments, revalidations, and updates under supervision. • Collect, organize, and maintain required ownership, managing employee, and practice location documentation. • Track CMS and MAC correspondence and assist with responses. • Collect and maintain required regulatory documentation for vendors and contractors. • Track expirables and ensure timely updates of required certifications and attestations. • Assist with regulatory onboarding and offboarding documentation. • Support credentialing activities, including license verification, certification tracking, and documentation management. • Maintain credentialing files and ensure alignment with enrollment and payer requirements. • Monitor expirables and notify leadership of upcoming renewals. • Maintain regulatory trackers, calendars, and filing logs. • Ensure records are organized, complete, and audit-ready. • Assist with internal audits and data validation reviews. • Coordinate with HR, Compliance, Operations, and Revenue Cycle to gather required information.