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Magdalena Ekielska

Quality Manager, Pharmaceuticals & Medical Devices
  • Suggested rate
    €400 / day
  • Experience8-15 years
  • Response rate100%
  • Response time1 hour
The project will begin once you accept Magdalena's quote.
Location and workplace preferences
Location
Warsaw, Poland
Can work onsite in your office in
  • and around Warsaw (up to 50km)
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Skill set (11)
Industry fields of expertise
Magdalena in a few words
A highly organized and detail-oriented Quality Manager with a
strong background in project management and business development,
including leadership positions in multi-site operations. Proven
expertise in developing and implementing global quality strategies,
ensuring regulatory compliance (FDA, EMA, GMP, ISO 9001, ISO 13485), and driving
operational excellence. Committed to fostering innovation, continuous
improvement, and maintaining the highest standards of quality
Experience
  • QAA USA/CAN/BENELUX Ascensia Diabetes Care
    Commercial Quality Representative
    September 2023 - Today (1 year and 6 months)
    • Manage operational processes for commercial quality in North American and Benelux regions.
    • Ensure compliance with regulatory requirements, including vigilance oversight in the US and Canada.
    • Lead cross-functional teams to develop and implement quality standards and process improvements.
    • Collaborate with marketing and supply chain teams to optimize product delivery and enhance customer satisfaction.
    • Develop and track KPIs to evaluate the effectiveness of commercial operations.
  • TAKEDA
    Regional Quality Lead EU / CAN / Quality Manager
    June 2021 - July 2023 (2 years and 1 month)
    • Direct operational quality oversight for the Regional Distribution Centers (RDCs) across Europe.
    • Deliver comprehensive training on deviation management and implement corrective actions.
    • Conduct GDP audits and assess compliance with Falsified Medicines Directive.
    • Improve quality performance by analysing key indicators and implementing improvement activities.
    • Strengthen collaboration across supply chain, site quality organizations, and LOC quality teams.
  • GlaxoSmithKline Consumer Healthcare
    Quality Assurance Specialist (Pharmacist)
    March 2021 - May 2021 (2 months)
    • Support batch assessment and product release in compliance with corporate frameworks.
    • Handle quality complaints and conduct risk assessments for corrective actions.
    • Enhance QA processes through document management and system implementation across EU operations.
    • Participate in investigations of deviations to maintain quality standards.
    • Direct writing and review operating procedures to ensure compliance, efficiency and clarity.
    • Implement new (IT) solution for GxP purposes within EU region.
Recommendations
Education
  • Lean in Services postgraduate studies
    Warsaw School of Economics
    2018
    Lean in Services postgraduate studies
  • Internal Auditor course
    Polish
    2017
    Internal Auditor course
  • Project Management – PMI methodology
    Altkom
    2015
    Project Management – PMI methodology
  • Coaching
    Warsaw School of Economics
    2012
    Coaching
  • M. Pharm
    Warsaw Mdical University
    1998