​Quality Assurance:

• Worked with three-person team to create Quality Management System (QMS) from inception and implemented/managed the subsequent life cycle of documents:

• Wrote, evaluated, and approved QMS procedures; reviewed team’s work and provided final approval of documents;

• Presented and defended QMS during eight audits by clients and four inspections by Belgian Health Authorities to ensure compliance of quality system and drug products with EU Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP);

• Conducted internal/external qualification and follow-up audits of internal processes, suppliers, and subcontractors’ systems;

• Reviewed batch records and released Biotechnological Investigational Medicinal Products (IMPs), including non-EU batches;

• Involved in the launch of four new IMPs used for clinical trials and/or compassionate uses (reviewing Investigational Medicinal Product Dossier (IMPD) prior submission to Authorities, ensuring compliance of master batch records, QC methods, raw/starting materials-, consumables- and Drug Product specifications, Drug Product- label template, packaging and storage conditions to IMPD, reviewing specific protocols for reproducibility batches, aseptic processes simulations, equipment and production operators qualifications, QC methods-, Drug Product stability-, packaging- and shipping validation, auditing and selecting involved suppliers and subcontractors, assessing any risk or change in project-related processes, following projects with clients, training and coaching dedicated QA team members, reviewing non conformities, implementing CAPAs and defending the quality management system during Competent Authorities’ pre-launch inspection);

• Approved validation/qualification protocols and reports for equipment, media fill tests, material integrity, reproducibility batches, material inlet, cleaning, gowning, quality control (QC) methods, shipping, HVAC, and environmental monitoring;

• Assessed quality-related training for QA team members and approved quality agreements with subcontractors, suppliers, and clients;

• Complied with IMPD when approving specifications, master batch records, and drug product labels;

• Analyzed risks while reviewing non-conformities, change control requests, practical challenges, and production process design in order to foresee issues and implement adequate CAPAs;

• Handled nonconformities by investigating impact and root cause, analyzing risks, and correcting the issue; defined and followed up on adequate CAPAs and related closure criteria;

• Authorized changes through change control process to QMS, raw materials, consumables, operational processes and organization, design of facilities, equipment location in clean rooms, replacement of equipment, temporary derogation to a procedure;

• Organized QA-RA group with representatives from eight companies to share regulatory updates, challenges, and experiences. Group invited by the Belgian Health Authorities to provide feedback on a new GMP guidelines project;

• Qualified to work in aseptic conditions (Grade A gowning qualification);

• Earned qualification to serve as Lead Auditor, auditing internal processes and suppliers’/subcontractors’ quality systems;

• Met all deadlines in a high-stress environment due to patients’ life-threatening diseases and short time constraint

Regulatory Affairs:

• Reviewed clients’ IMPDs to ensure compliance with European standards/operational practices and provide tips on strategic writing;

• Drafted clinical trial protocol to obtain human body material supply in order to train production operators on cell culture;

• Submitted demands and declarations to the Ministry of Health according to national requirements;

• Performed Regulatory Vigilance for GMP/GDP activities: follow-ups with industry groups’ newsletters, authorities’ updates, continuous training, and networking;

• Prepared customs documents for animal derived-products imported from outside EU.

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Team Leadership:

• Supervised, coached, and inspired a four-member team, familiarizing two members with GMP/GDP and leading by example. Defined training plans and developed team’s competencies;

• Led weekly team meetings, interviewed candidates, evaluated employee performance, and promoted two team members;

• Delivered basic GMP training for new hires and trained employees seeking qualified auditor roles.