• Facilitate compliance program that enables innovation while ensuring legal adherence • Support business growth with monitoring of regulatory developments • Collaborate with internal stakeholders to develop compliant solutions • Maintain procedures and documentation for regulated activities • Review and negotiate contracts for regulatory compliance

• Serve as the primary compliance and governance contact for assigned MSP and MSSP clients. • Guide clients through compliance readiness efforts, including planning, documentation, policy development, evidence preparation, and auditor-facing coordination. • Own the onboarding and ongoing service experience for compliance-focused MSSP clients. • Prepare and deliver compliance-focused security QBRs, cadence calls, and client status updates. • Write, update, and maintain Written Information Security Programs, security policies, governance documentation, and related client-facing materials. • Help scope, coordinate, and manage compliance and security projects to ensure work is scheduled, communicated, and delivered on time. • Support Microsoft Purview, data governance, sensitivity labeling, and Bronze/Silver/Gold data classification initiatives for Endsight and its clients. • Advise internal leaders on compliance, governance, data protection, and risk management needs. • Coordinate with security analysts, Client Strategy Managers (CSMs), consultants, leadership, and client stakeholders to keep compliance work moving. • Participate in customized cybersecurity awareness training efforts for clients. • Support the security team's shared SOC alert and on-call process by assisting with initial triage and communication when needed. This is not a hands-on technical support role.

• Independently establish and execute sponsor oversight programs for clinical trials, including CRO qualification, ongoing performance monitoring, and risk-based quality oversight aligned with ICH E6(R3) • Serve as the independent quality liaison between client sponsors and CROs, central labs, IRT/RTSM vendors, eCOA/ePRO providers, central imaging vendors, bioanalytical labs, and clinical supply CMOs • Author and approve quality agreements with clinical vendors; review and approve clinical vendor SOPs, validation documentation, and oversight plans before study start • Drive direction of the clinical quality function within client organizations — establish the quality oversight model, define escalation pathways, and align sponsor and vendor responsibilities • Independently plan, conduct, and report GCP audits, including investigator site audits, CRO/vendor system audits, TMF audits, clinical database audits, and for-cause audits • Lead pre-approval inspection (PAI) readiness and BIMO inspection preparation for sponsor clinical sites and key vendors; conduct mock inspections • Author audit reports with defensible findings, regulatory citations, and severity classifications; track CAPA commitments to closure • Build and maintain audit programs (risk-based audit plans, annual schedules, audit metrics) for client sponsors • Review and approve clinical trial documents prior to use — protocols and amendments, ICFs, IB updates, monitoring plans, data management plans, statistical analysis plans, and clinical study reports — for GCP compliance and inspection-readiness • Oversee TMF quality: review TMF completeness, contemporaneousness, and ALCOA+ compliance; advise on eTMF system configuration, indexing, and QC processes • Approve essential documents for clinical trial start-up, including site selection packages, regulatory submissions support documentation, and IRB/EC correspondence • Lead investigations into serious GCP issues including protocol deviations of significance, data integrity concerns, informed consent issues, IP accountability discrepancies, and suspected fraud or misconduct • Author and approve CAPAs arising from audits, inspections, and quality events; ensure effectiveness checks are designed and executed • Advise client sponsors on quality issue escalation, including determination of reportability to regulatory authorities and IRBs/ECs • Provide quality input on regulatory submissions — IND, IMPD, CTA, NDA/BLA/MAA clinical modules — and represent the quality function during regulatory authority interactions • Lead client inspection support during FDA BIMO, EMA, MHRA, or other Health Authority inspections of sponsors, sites, or vendors • Maintain current knowledge of evolving GCP regulations and guidance (ICH E6(R3), ICH E8(R1), FDA decentralized clinical trial guidance, EU CTR, ICH E2A/E2B, 21 CFR Parts 11/50/54/56/312/812) and translate changes into actionable client recommendations • Independently manage multiple concurrent client engagements; serve as the senior quality point of contact and represent Syner-G at client governance and steering committee meetings • Expand existing accounts by identifying additional quality gaps and proposing scope extensions; support proposal development and SOW authorship for new GCP work • Contribute to Syner-G's GCP service offering — develop reusable templates, audit checklists, training content, and thought-leadership materials.

• Manage Pall Corporation’s Export Compliance program globally • Develop and implement export compliance improvement processes including export screening, licensing, and classification • Serve as the subject matter expert on US export controls including EAR and ITAR • Collaborate with site leaders to ensure internal controls regarding EAR and ITAR compliance • Draft and submit TAA’s, MLA’s, and US export license applications