• 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

• Review, interpret, and understand National Highways technical documentation, standards, and compliance requirements. • Prepare and manage the product technical file in line with National Highways specification. • Identify gaps between existing product documentation and required compliance standards. • Coordinate the collection of technical evidence, certifications, test data, and supporting documentation. • Drive the product acceptance process through to completion by the December deadline. • Read and analyse technical product documentation, compliance files, and authority specifications. • Translate compliance requirements into clear actions for internal engineering and technical teams. • Ensure all technical documents are accurate, complete, structured, and submission-ready. • Maintain version control and auditability of all compliance-related documentation. • Liaise closely with technical teams in Germany and the UK. • Act as the key point of contact between the client and relevant highways or government authority stakeholders where required. • Understand and navigate the expectations of organisations such as National Highways, local highways authorities, and Transport for London. • Support communication between commercial, technical, and regulatory stakeholders. • Understand the commercial importance of achieving product acceptance within the target timeframe. • Support the client in positioning the product appropriately for use within UK highways and transport infrastructure. • Help interpret the nuances of working with government bodies, public authorities, and transport agencies.

• Report to the Head of Global Compliance. • Ensure overall cGMP compliance profile is maintained. • Develop and implement compliance processes and systems consistent with global quality systems requirements. • Engage with key global regulators to assure that practices and policies meet current regulatory expectations. • Support the established Quality Compliance strategy. • Work on continuous improvements regarding national and international cGMP compliance standards. • Develop and execute inspection readiness programs. • Provide guidance on compliance-related matters. • Develop education training regarding regulatory requirements.