| | | 20,000+ Fresh Resumes Monthly | |
|
|
| |
Click here or scroll down to respond to this candidateCandidate's Name
St. Louis, Missouri PHONE NUMBER AVAILABLE EMAIL AVAILABLE
LINKEDIN LINK AVAILABLEQuality & Compliance Director10+ years of experience in pharmaceutical quality assurance, regulatory compliance, and procurement. Improved supplier and laboratory compliance by 20% within 1 year, resulting in$500,000 annualized cost savings. Reduced non-compliance incidents by 300% and enhanced operational efficiency by 35% within 2 years. WORK EXPERIENCEBene Arzneimittel Gmb H Geretsried, Bavaria, Germany 02/2022 - Present US FDA Regulatory AgentClayton Pharmacy Clayton, Missouri, USA 07/2011 - Present Lab Manager/QA ConsultantHealth & Wellness Compounding Pharmacy Nashville, Tennessee, USA 03/2014 - 07/2016QA Compliance ManagerEnhanced inquiry response time by 50%, leading to efficient import processes and improved communication with foreign establishment chemicals within two (2) quarters.Led impactful FDA inspections of foreign establishments, resulting in a 100% increase in regulatory adherence, strengthening consumer health and trust continuing in 2022.Optimized communication between FDA and foreign establishments, resulting in a 25% decrease in regulatory discrepancies, ultimately improving compliance and business operations.Negotiated 100s of contracts and quality agreements, leading to a 45% reduction in laboratory expenses and improved overall quality control.Boosted lab compliance by 25% with strategic audits, resulting in streamlined operations and reduced risk within two quarters.Ensured trust in work quality with a thorough triple check system, resulting in error rate below 0.5% and increased precision in 6 months.Generated annual cost savings of over $500,000 by optimizing lab operations and streamlining pharmaceutical chemical purchase agreements, boosting overall operational efficiency.Successfully drove a 20% increase in operational efficiency through the implementation and sustainability of continuous quality improvement programs, leading to enhanced compliance and regulatory adherence within 6 weeks.EDUCATIONBachelor Of Science In Biological And Biomedical Sciences Excelsior CollegeCERTIFICATIONSFDA Inspections : From Site Preparation To Response 01/2024 FDA Inspections Of GMP Facilities : How To Be Inspection Ready 01/2024 Certified Pharmacy TechnicianPTCBCAPA 01/2024Good Manufacturing Practices (GMP) 01/2024Verified International Academic Qualifications 04/2023 Basic Life SupportClean Room CertificationSterile Products (Iv) CertificationSKILLSAccount Analysis, Biomedical Research, Business Analytics, Business Management, Business Planning, Code of Federal Regulations, Continual Improvement Process, Contract Negotiation, Corrective and Preventive Action, Cost Efficiency, Cost Reduction, Customer Expectation Management, Drug Safety, External Auditing, Good Manufacturing Practices, Laboratory Management, LESS, Market Share, Medical Device, Microsoft Excel, Operational Efficiency, Passionate, Pharmaceutical Compounding, Pharmaceutical Industry, Pharmacology, Private Equity, Problem Management, Product Development, Product Management, Project Management, Quality Control, QuickBooks, Real Estate, Regulatory Compliance, Resource Optimization, Revenue Growth, Risk Analysis, Root Cause Analysis, Standard Operating Procedure, Sterility Assurance, Streamlining Process, Vendor Contracts Enhanced regulatory compliance by 25% through proactive risk assessment and continuous improvement, resulting in reduced legal issues and improved brand reputation.Revamped QA compliance procedures, leading to a 280% reduction in non-compliance incidents within 4 months, safeguarding regulatory adherence and minimizing risk for the company. |
