Kamila Korkieniec
Associate Director | Clinical Supply Chain & Quality Management Expert
Wolomin
Profil zawodowy
Accomplished Biotech and Pharmaceutical leader with over 15 years of experience spanning Clinical Supply Chain Management, Quality Assurance (QA/QM), and GMP operations. Proven track record of managing complex global supply chains for multi-phase clinical studies, leading cross-functional teams, and upholding rigorous regulatory standards (GMP, GDP, GCP). Skilled in optimizing process efficiencies through Lean Six Sigma methodologies and managing high-performing teams in fast-paced corporate environments.
Podsumowanie
2
2
Languages
7
7
years of post-secondary education
22
22
years of professional experience
Doświadczenie
Associate Director - Clinical Supply Chain
AstraZeneca Pharma Poland Sp. z o.o.
Warsaw
2024.05 - Current
- Team Leadership: Provide strategic leadership to a team responsible for establishing global clinical study supply chains, ensuring consistent delivery across time, cost, and quality metrics.
- Operational Strategy: Drive continuous improvement initiatives to enhance efficiency, flexibility, and productivity across the global Supply Chain network.
- Compliance & Quality: Hold ultimate accountability for SHE/GMP compliance; lead quality investigations, deviations, CAPAs, and change controls to timely closure.
- Resource Planning: Oversee capacity and resource planning for the Clinical Study Supply Chain division.
Senior Clinical Supply Study Lead
AstraZeneca Pharma Poland Sp. z o.o.
Warsaw
2022.01 - 2024.04
- Complex Logistics: Managed end-to-end supply chains for complex, multi-phase clinical trials, holding total accountability for Investigational Product (IP) delivery.
- Process Ownership: Served as the Global Packing Network Leader and Owner of the Packing Process, driving cross-functional improvements.
- Mentorship: Mentored experienced colleagues and led global study setup enhancements.
Clinical Supply Study Lead/ Supply Chain Study Manager
AstraZeneca Pharma Poland Sp. z o.o.
Warsaw
2018.09 - 2022.01
- Protocol Translation: Translated complex clinical study protocols into accurate product demand forecasts.
- Vendor & IRT Management: Collaborated with CRO partners on packaging/labeling contracts, defined IRT user requirements, and established cost plans.
- Quality Facilitation: Acted as Site Deviations Facilitator, managing quality issues and coordinating QA site visits.
Project Manager
OncoArendi Therapeutics SA
2018.03 - 2018.08
- Manufacturing Oversight: Supervised the preparation and execution of active substance and medicinal product manufacturing processes under strict GMP rules.
- Audit & Documentation: Reviewed manufacturing documentation and led audits of drug product manufacturers.
Quality Assurance Specialist
Polfa Warszawa SA
2017.11 - 2018.03
- Quality Auditing: Organized and executed internal audits and managed the handling of market product returns.
- Agreements & CAPA: Revised and approved Quality Assurance Agreements (QAA) and monitored CAPA compliance.
Corporate QM Manager
Midas Pharma
2007.09 - 2017.11
- Global Auditing: Served as Lead Auditor qualifying API and Finished Dosage Form (including sterile product) suppliers globally.
- Regulatory Support: Prepared suppliers for local authority inspections and supported regulatory registration processes.
- QMS Maintenance: Authored Standard Operating Procedures (SOPs), managed ERP supplier data, and delivered company-wide internal training.
Laboratory Researcher (Molecular Membrane Biology)
Polish Academy of Science
2005.04 - 2007.07
- Contributed to molecular biology research projects, specializing in the production of recombinant proteins.
Wykształcenie
Post-graduate Diploma - Quality Management
Warsaw Economic University
2007.01 - 2009.01
M.Sc. - Biotechnology (Biochemistry & Microbiology)
Warsaw University of Life Sciences
2002.01 - 2007.01
Umiejętności
- Regulatory Expertise: Deep knowledge of European Pharmaceutical Law, GMP, GLP, GDP, GCP, ICH, and EMA requirements
- Strategic planning
- Certified Auditor of Integrated Quality Management Systems (ISO)
- Applied Project Management Certificate
- Lean Six Sigma training
- Systems & IT: TrackWise, ERP Systems, Computerized System Validation, MS Office Suite
- Laboratory Tech: PCR, HPLC, GC, UV, TLC, Electrophoresis, Western Blot
- Decision-Making proficiency
- Talent Management
- Supply chain operations
- Project coordination
- Motivational leadership
Websites, Portfolios, Profiles
[LinkedIn Profile Link]
Languages
English Fluent (Professional Working Proficiency)
Advanced
C1
German Good
Elementary
A2
Zainteresowania
Literature, music, film, biotechnology, ecology, sport
Personal qualities
Adaptable, organized, quick learner, ability to work under stress, good sense of humor
Oś czasu
Associate Director - Clinical Supply Chain
AstraZeneca Pharma Poland Sp. z o.o.
2024.05 - Current
Senior Clinical Supply Study Lead
AstraZeneca Pharma Poland Sp. z o.o.
2022.01 - 2024.04
Clinical Supply Study Lead/ Supply Chain Study Manager
AstraZeneca Pharma Poland Sp. z o.o.
2018.09 - 2022.01
Project Manager
OncoArendi Therapeutics SA
2018.03 - 2018.08
Quality Assurance Specialist
Polfa Warszawa SA
2017.11 - 2018.03
Corporate QM Manager
Midas Pharma
2007.09 - 2017.11
Post-graduate Diploma - Quality Management
Warsaw Economic University
2007.01 - 2009.01
Laboratory Researcher (Molecular Membrane Biology)
Polish Academy of Science
2005.04 - 2007.07
M.Sc. - Biotechnology (Biochemistry & Microbiology)
Warsaw University of Life Sciences
2002.01 - 2007.01