Managed full project lifecycles across operations, production, and scientific departments, ensuring timely delivery within scope and budget in strict GxP-regulated settings.

Provided QA oversight for all operations, ensuring that regulatory and compliance aspects are met, aligned with company standards, and logged in QMS.

Initiated and owned change controls, developed and conducted comprehensive impact assessments, and set up change actions to ensure alignment and compliance with regulations and Q&R requirements across all processes.

Directed regulatory projects to achieve compliance with IVD/MD regulations, ISO 15189,and ISO 13485.

Established and maintained risk management frameworks, including conducting risk analysis based on ISO 14971, identifying and mitigating project risks, and developing contingency plans to ensure compliance and project continuity.

Handled audits and managed regulatory submissions for RvA.

Participated in internal and external audits (clients), managed change controls, performed root cause analysis, handled quality events (QE), and established sustainable corrective and preventative actions (CAPA) within the QMS (Veeva Vault, Bizzmine).

Presented PM and Q&R topics during change control review boards, stakeholder meetings, and steering committee meetings.

Ensured that employee training procedures are developed and properly documented.

Key competencies and skills: Strong regulatory knowledge and adherence Proficient in multiple project management methodologies (Lean, Agile, Waterfall)

Consistently delivered excellent results while working in a highly sensitive work environment

Responsible for business development, planning, staffing, negotiations with local and international partners, sub-contractors, international healthcare stakeholders ( EUAM,OSCE, NATO, Embassies and consulates).

Performed budgeting ,financial control and reporting;

Developed business plans, strategies, set goals, tracked KPIs;

Build and managed a strong team of professionals and objectives;

Digitalization (CRM system, EPR)

Advisory and consulting in ISO 9001 compliance for medical facilities. Providing comprehensive audit of medical facilities in term of Quality assurance, patient satisfaction and risk management, aiming to assure compliance with local national and international accreditation standards Quality improvement audit of services performed, patient satisfaction, and the financial cost within medical facility

Responsible for: management, planning, and coordination of a project's activities to ensure that goals or objectives of the project are accomplished within prescribed time frame and funding parameters; fundraising and project resources mobilization; project strategy development and implementation, ensure that program quality standards are integrated at all stages of project; ensure that projects meet expected results, and comply with donor requirements staffing, leading and managing people on the project; developing strategic partnerships with potential stakeholders and subcontractors working closely with the Ministries (MOH, MOF) and Parliament, institutional governmental donors (IRD Crim), INGOs and civil society in terms of implementing changes; monitoring of expenditure of the project VS planned in budget. Ensure that projects meet expected results, and comply with donor requirements; coordinate cross-functional meetings with various stakeholder in multiple functional areas to meet project goals.

Advising on legal and management structure of the ukrainian health system reform and medical insurance related issues identifying an appropriate budget model through evaluation of services , processes , and procedures in terms of their costs , and measures their effectiveness as a first step to public healthcare insurance implementation. drafting amendments and recommendations to laws ( by - laws ) , reviewing relevant policies , legal and research documents , international , regional and national obligation in hiv / aids

Drafted changes in the current quality and audit regulations conducted trainings for medical facilities on risk management , patient safety , hospital safety index reviewing existing documents on quality control and standardization in secondary health care and evaluating their appropriateness to modern eu instruments and practices as a part of expert team , drafted methodology for developing medical standards and local clinical pathways in ukraine based on eu standards drafted recommendations to the clinical audit mechanism in ukraine conducted a safety check compliance audit based on jci accreditation standards