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Ikay Eguavoen

@ikayeguavoen

QMS Implementation Lead at Bit Bio, implementing an eQMS across quality modules to support GMP and ISO compliance.

At Bit Bio, I lead the implementation and optimisation of an electronic Quality Management System, from configuration and data migration through validation and user acceptance testing. I configure quality modules including document management, CAPA, deviations, and change control to support regulatory compliance and business adoption.

Previously, I integrated an eQMS as QMS Manager at Royal Mail Health and developed procedures aligned with ISO 9001 and GDP. Across pharmaceutical, biotechnology, medical-device, and distribution environments, I’ve worked on audits, supplier quality, remediation, and continuous improvement, including reducing supplier-related issues by 30% at Royal Mail Health.

Experience

Work history, roles, and key accomplishments

Current

QMS Implementation Lead

Current

Bit Bio

Mar 2026 - Present (7 months)

Leading the implementation and optimisation of an electronic Quality Management System (eQMS) ensuring compliance with GMP, GxP, ISO 9001, ISO 13485, 21 CFR Part 11 and EU Annex 11. Managing end-to-end implementation including project planning, system configuration, data migration, validation, UAT and business adoption.

QMS Consultant

Alvotech

Aug 2025 - Nov 2025 (3 months)

Assessed and refined Quality Management Systems to assure alignment with regulatory standards and organisational goals. Implemented data migration strategies boosting system integrity and compliance by 20% and delivered training programs enhancing team proficiencies.

QMS Regulatory Compliance Data Migration Training KPI Monitoring Compliance Audit

QMS Manager

Royal Mail Health

May 2024 - Jul 2025 (1 year 2 months)

Integrated an electronic Quality Management System (eQMS) improving compliance execution. Developed QMS procedures for ISO 9001 and GDP alignment, reduced production inefficiencies by 15%, and led a team of quality professionals.

EQMS ISO 9001 GDP Process Audits Compliance Supplier Quality Team Leadership Audit Management

GMDP Consultant

Mundipharma

Jan 2024 - Apr 2024 (3 months)

Performed remediation activities to ensure GDP compliance and inspection readiness. Led quality oversight of CMOs and suppliers, designed quality metrics dashboards, and managed key QMS subsystems.

GDP GxP CMO Management Audit Risk Based Monitoring QMS KPI Dashboards Deviations CAPA Change Control Quality Technical Agreement

Quality Assurance Consultant

Recipharm

Oct 2022 - Dec 2023 (1 year 2 months)

Developed quality strategies resulting in reduced defects and increased customer satisfaction. Managed the QC department and led QA projects, implementing data-driven quality metrics that reduced product nonconformities by 30%.

Quality Assurance Quality Control Management Validation Protocols ICH Q1A(R2) Stability Protocols APQR Analytical Methods Validation Regulatory Compliance Data Driven

QMS Consultant

Indivior

Feb 2022 - Sep 2022 (7 months)

Led a complete analysis of change control protocols resulting in streamlined workflows. Chaired impact assessment meetings and played a pivotal role in Quality approval for a major SAP change project.

Change Control Impact Assessments SAP Continuous Improvement External Supply Operational Efficiency

Quality Assurance Specialist

Pharmanovia

Sep 2020 - Feb 2022 (1 year 5 months)

Managed CAPA operations and orchestrated deviation management initiatives. Provided support for RP & QP release activities and performed vendor/customer approvals and gap analysis against current legislation.

CAPA Deviation Management EU GMDP QP Release WDA Supplier Approval Gap Analysis