• Establish and operate governance frameworks across full transition lifecycles (feasibility through stabilization). • Support steering committees and project boards while enforcing strict delivery methodologies. • Identify, log, and mitigate critical risks and interlocks across multiple cross-functional workstreams, driving swift escalations and resolutions. • Validate that enterprise processes align with internal controls, corporate policies, and data protection regulations (e.g., GDPR), supporting secure data migrations and system access. • Maintain structured documentation and decision logs to support internal/external audits. • Deliver transparent, KPI-driven status reporting to senior executives. • Balance aggressive project timelines with stringent compliance mandates, partnering seamlessly with executive leaders across matrixed organizations.

• Establish and operate governance frameworks across full transition lifecycles (feasibility through stabilization). • Support steering committees and project boards while enforcing strict delivery methodologies. • Identify, log, and mitigate critical risks and interlocks across multiple cross-functional workstreams, driving swift escalations and resolutions. • Validate that enterprise processes align with internal controls, corporate policies, and data protection regulations (e.g., GDPR), supporting secure data migrations and system access. • Maintain structured documentation and decision logs to support internal/external audits. • Deliver transparent, KPI-driven status reporting to senior executives. • Balance aggressive project timelines with stringent compliance mandates, partnering seamlessly with executive leaders across matrixed organizations.

• Work on a variety of assignments, diverse product types for clients • Creating opportunity for clients throughout the product lifecycle • Sharing scientific, technical, regulatory, and/or commercial expertise • Leading teams of respected SMEs • Meeting new situations and learning • Provide mentoring and guidance to other RS employees

• Serve as SME for controlled document management, ensuring compliant governance and inspection readiness • Author, review, approve, and manage controlled procedures and quality documents per GxP requirements • Drive document lifecycle management activities including creation, revision, periodic review, and archival • Provide guidance on procedural writing standards and document management best practices • Support GxP training governance to ensure compliance with regulatory requirements • Maintain effective training curricula aligned with role-based responsibilities and procedural updates • Monitor training compliance metrics and support remediation of non-compliant records • Lead regulatory compliance activities across global GxP operations • Drive inspection readiness initiatives and support FDA, EMA, MHRA, and other health authority inspections • Monitor evolving regulatory requirements and implement compliance strategies • Support development of remediation plans for audit findings and compliance gaps • Manage QMS processes including deviations, CAPAs, change controls, SOP management, and document control • Utilize metrics and trend analysis to identify compliance risks and drive continuous improvement • Support harmonization of quality processes to improve scalability and effectiveness