MELODY FARKAS

• Directe activities across Quality Assurance, Quality Operations, and Compliance departments.
• Make sound, risk-based GMP decisions based on make decisions based on data and in compliance with policies and procedures
• Led site through successful regulatory and client inspections
• Liaises with regulatory bodies such as FDA, Health Canada, EMA
• Partner with SLT to establish and champion Quality Culture.
• Advises executive management on quality issues that may affect the site or the Company as a whole
• Collaborated with senior leadership to set long-term objectives for the company.Develop and implement strategic plans to ensure organizational goals are met.
• Collaborate cross-functionally to expedite work and improve collaboration.
• Analyzed data to inform decision-making and strategic direction.
• Managed crisis situations to minimize impact on operations and reputation.
• Facilitated professional development to build a high-performing team
• Formed and sustained strategic relationships with clients.

• Led quality management team at Softgel manufacturing and packaging site
• Conducted assessments of site and staff preparation to ensure successful FDI PLI/PAI at Viral Vector facility in Seneffe, BE.

Led a team of QA leaders responsible for managing quality operations and systems clinical supply manufacturing, packaging, and distribution site

Collaborated cross-functionally to drive KPIs (RFT, OTD, OTJF, CAS) and revenue targets

• Developed goals and objectives for Quality department and managed team performance

• Led the Quality team through implementation of commercial packaging business by establishing new processes and integrating into existing quality systems

Managed successful audit to restore business relationship with key client

• Facilitate cross-departmental collaboration to maintain quality standards in product delivery.
• Participated in client business reviews to demonstrate site's dedication to Quality.
• Managed QA Department operations for laboratory review, batch review, and product disposition.
• Managed QA Project Leads for development and clinical batch production.
• Increased review productivity by 30% in 2018, ensuring quality metrics were upheld.
• Reviewed and approved validation protocols and reports.
• Championed deployment of Insightful Investigations and 'Made For' strategies.

• Directed team of QA leaders ensuring adherence to quality and compliance standards in Commercial and PDS production.
• Collaborated with site leadership to enhance RFT, OTD, and CAS metrics.
• Facilitated workshops to equip leaders and operators with skills for FDA audit readiness.
• Co-hosted successful audits with FDA and Belarus regulatory bodies.
• Directed efforts leading to 86% reduction in overdue compliance backlog.

• Delivered on-site quality consulting services to clients.
• Site Quality Head for Importer
• Reviewed and approved batch records, change controls, deviations, master documentation, SOPs, APRs
• Managed renewal and maintenance of establishment licenses

• Managed packaging team of 100 operators and professionals to achieve quality, compliance, and cost targets.
• Managed Operational Quality to investigate deviations, develop and implement CAPA
• Oversaw receiving and warehouse operations

• Established successful softgel packaging division at Accucaps, managing capital projects to boost capacity.
• Led the packaging organization through purchasing of equipment, development of processes and procedures, recruitment and hiring, interdepartmental integration of processes
• Partnered with Quality to integrate packaging department into quality systems leading to FDA site approval with zero 483s, Health Canada approval, and 20+ positive customer inspections
• Established and managed execution of self-inspection program to evaluate packaging systems against internal procedures and GMP regulations
• Led cross functional teams to successfully deliver over 100 on-time launches and 400+ SKUs
• Drove continuous improvement projects to reduce changeover time by 50%, reduce cost of goods by 20%
• Simplified batch documentation increasing right first time metrics

• Managed teams across 3 warehouses to achieve safety, quality, and performance goals
• Oversaw budget management to align with corporate objectives.

• Designed and implemented electronic warehouse management system to optimize distribution of antiretrovirals to rural clinics in western Kenya
• Trained community health workers in preventive health care to enhance effectiveness of home visits.
• Coordinated community event focused on water sanitation and hygiene awareness.

• Oversaw operations of five liquid and topical manufacturing suites and two packaging lines to achieve quality, compliance, and cost objectives.
• Designed engineering solution to resolve technical formulation issue resulting in savings of over $2 million annually
• Earned team recognition award for development of high throughput recruitment process

• Technical Writer, Quality Assurance Business Systems
• Supervisor, Quality Control
• Quality Control Chemist, Microbiologist
• Research Associate