i am comfortable with complexity and my diverse work and study background equipped me as international Pharmaceutical Industry Leader. i have worked in challenging and multi-cultural environments at country, branch and business unit levels, where i have built strong and agile winning teams.
i am a Pharmacist and certified internal GMP Auditor. i currently work as GMP and pqms Consultant to a cape town based CMO. as business unit head i am experiences in various aspects of Compliance management.
QA ConsultantCape Town, South Africa
Since August 2016
- Pharmaceutical Quality Systems (ich q10) and quality Risk Management systems (ich q9), continuous improvement process, capas and Change Control.
- master Validation plan for hvac, ro water, environment and cleaning, Training, Change Management, quality reviews, internal inspections and vender audits.
- site preparation for ra and client audits.
- Pharmaceutical Quality Systems (ICH Q10) and Quality Risk Management Systems (ICH Q9), continuous improvement process, CAPAs and change control.
- Master Validation Plan for HVAC, RO Water, Environment and Cleaning, Training, Change Management, Quality Reviews, Internal inspections and Vender Audits.
- Site preparation for RA and Client audits.
Head of Prescription Medicines KazakhstanJanuary 2013 --- July 2016
- responsible for Sales and Marketing, commercial Operations, Regulatory Affairs for pm and chc as well as pv for central asia regions countriies
- improved market position in all Therapeutic Areas
- established a branch office in kazakhstan.
- gdp audits on 3pl companies.
- responsible for all aspects of Compliance including risk assessments of Healthcare Compliance and personal data protection, anticorruption, antitrust, insider trading, antidiscrimination and export control & trade.
- established a stroke prevention and Treatment program in a ppp with the moh. (actilyse).
Project Manager Emerging Markets InternationalMay 2010 --- December 2012
- project managed a corporate cross-functional team, to develop and implement a portfolio Strategy for emerging market countries and supported national project teams.
- identified, sourced or developed products, ensuring quality and legal Compliance and achieving registration.
- conducted Due Diligence and 3pm quality audits.
- developed oncology portfolio for turkey, Respiratory for different countries, line extensions for russia.
Various Roles Sub-Sahara AfricaJuly 2004 --- April 2010
- responsible for quality and Compliance as responsible Pharmacist.
- Member of executive committee and various Business Development teams.
- market entry in east africa for all business units. market scoping, selection and Segmentation, product and channel selection, Partner assessment, selection and contracting. developing and implement launch strategies for the territory.
- Member of Pharmaceutical task group on national Health insurance
- global relationship manager for international ngo’s for the supply of anti-retroviral drugs to lower income countries.
- Member of various new product launch teams.
- team Member that developed global Supply Chain regulations with focus on gdp, cold chain shipments and Supply Chain integrity.
- planned and managed the phase out of cfc containing inhalers for south africa, south america, central european countries and south-east asian countries
Various Positions South AfricaJuly 1987 --- April 2000
- CEO of sandoz south africa and Member of international Product Development team
- post merger integration of people and osdf plant transfer (350 products)
- Business Development Manager: 1997 - 1997
- project and exports manager: 1994 – 1996
- Sales Manager: 1992 - 1994
- Product Manager voltaren (diclofenac): 1989 - 1992
- sales and product Trainer: 1988 – 1989
- Hospital representative responsible for state tenders: 1987 – 1988
Analytical thinkingAssertivenessStrategic thinkingProblem solvingApproachabilityCreative thinkingInnovative thinkingInterest in knowledge
GenericGeneric PharmaceuticalsBiosimilarsCustomer RelationsAccount ManagementBusiness Process ImprovementBusiness StrategycGMPChange ManagementCoachingComplianceContinuous ImprovementCross-functional team leadershipInternational Project ManagementLeadershipLife SciencesMarketing StrategyMicrosoft ExcelMicrosoft OfficeMicrosoft ProjectMicrosoft WordMicrosoft PowerpointNew Business DevelopmentPharmaceutical ManufacturingProcess improvementProduct managementProject ManagementProject Portfolio ManagementRisk ManagementRoot Cause Analysis (RCA)Sales EffectivenessStrategic PlanningSupply Chain ManagementTeam Leadership
Skills and Expertise
Administer logisticsAdvise on strategy Analytical skills Analyze dataAchieve sales objectivesAttend at steering committee meetingsAttend steering committeeCoachCoordinate logisticsCoordinate projectsCoordinate recallsData miningDefine market needsDevelop business planDevelop marketing strategiesDevelop supply strategyDevelop supply plansDirect co-workersDirect co-workers to achieve resultEstablish contractsEstablish professional relationships with partnersEstablish relationships with Key Opinion LeadersEvaluate licensing opportunitiesForecasting of drug productIdentify risksImplement marketing plansInteract with KOLInventory ManagementLabeling compliance with local regulationsLiaise with professionals in other divisions of the company as requiredlifescienceMaintain Key Account plansMaintain strong relationshipsManage budgetsManage complexityManage contractors Organise steering committeePeople managementproject managementWork cross-functionally
Master’s Degree in Engineering/Industrial Management from University of Pretoria/Universiteit van Pretoria in 1997
Post graduate Honours Degree in Marketing/Marketing Management, General from University of South Africa/Universiteit van Suid-Afrika in 1994
B.Pharm in Pharmacology, Pharmaceutics, Chemistry from North-West University/Noordwes-Universiteit in 1983
Training and Certification
Leadership Development Novartis in 1999 Training
Negotiation Skills in 1997 Training
Advanced Marketing Management in 1990 Training
Quality Practitioner (CQI) in 2018 Certification
Internal GMP Auditor (IRCA) in 2017 Certification
Qualified Person in 2000 Certification
Financial Management for non-finance managers in 1995 Certification
Becoming a Triple-Threat Project Manager in 0000 Certification
Big Data Foundations in 0000 Certification
Data Science and Analytics Career Paths and Certifications in 0000 Certification
Introduction to Data Science in 0000 Certification
Project Management Simplified in 0000 Certification
The Basics of Data for Analytics in 0000 Certification