Magdalena Ekielska
Brwinow / Warsaw
Summary
A highly accomplished and detail-oriented Quality Assurance Manager and Pharmacist with extensive experience in External Manufacturing Quality Assurance Deep expertise in EU GMP, ICH guidelines, and GDPR standards, utilizing a risk-based approach to ensure compliance and manage the quality performance of Contract Manufacturers. Proven ability to lead supplier qualification, change control, and complaint investigations, coordinate batch release with Qualified Persons and drive continuous improvement initiatives anchored in proactive risk mitigation. Seeking to leverage expertise in a remote Contract role in Poland.
Overview
9
9
years of professional experience
Work History
Commercial Quality Representative
Ascensia Diabetes Care
09.2023 - Current
- Act as a Primary Quality Contact for commercial operations in the USA and Canada, establishing and maintaining relationships with key external stakeholders, including customers, suppliers, distributors, and regulatory agencies.
- Ensure operational standards and procedures maintain compliance with regulatory requirements and industry best practices.
- Ensure vigilance oversight in Canada and USA, including monitoring and reporting adverse events or incidents to Health Canada.
- Provide leadership and support to cross-functional teams involved in commercial operations, fostering collaboration and driving results.
Regional GDP Quality Lead EUCAN / QM
Takeda
06.2021 - 07.2023
- Provided operational quality oversight for Regional Distribution Centres in Europe, ensuring compliance with QMS and local regulatory requirements.
- Responsible for evaluating and confirming the qualification of suppliers to ensure they met the required regulatory criteria for the assigned Regional Distribution Centre.
- Established or supported the establishment of Quality Agreements and Transitional Service Agreements related to (analogous to external partners).
- Drove and ensured timely resolution of product quality & compliance in Regional Distribution Centre.
- Evaluated GMP/GDP compliance and risks through KPI and drove the implementation of improvement activities (continuous improvement).
- Oversaw and assessed the implementation of Change Controls and provided training on Deviation Management using TrackWise.
Responsible Person for GDP, Supply Chain Quality Manager
PF Consumer Healthcare Poland Sp. z o. o. (Pfizer/GSK - project)
12.2019 - 05.2021
- Led the Qualification of Suppliers and Customers, confirming they met criteria required by regulations.
- Adapted global Quality Agreement forms for local purposes, including QA with Logistic Service Providers (External Service Provider/CMO).
- Interacted with Global and regional Regulatory Affairs and Quality Assurance (cross-functional alignment).
- Coordinated wholesale premises and critical systems qualification.
- Assisted the batch assessment / release process within the regulatory and corporate framework to ensure product release.
- Led Quality Complaints handling (including medical devices and combo products).
- Participated in investigation of deviations and stock queries, implementing preventive and corrective actions.
- Direct writing and review operating procedures to ensure compliance, efficiency and clarity.
Deputy Responsible Person for GDP, QAS
DAMCO Poland (Maersk Group)
06.2016 - 11.2019
- Responsible for the Qualification of Suppliers and Customers, ensuring they met criteria required by GDP and other relevant regulations.
- Managed the technical agreements with suppliers and service providers (External Partners).
- Ensured the timely resolution of Quality issues with internal and external partners and raised Quality Incidents as appropriate.
- Supported and carried out external and internal audits.
- Implemented corrective and preventive actions to drive improvement across the supply chain.
- Led Quality Complaints handling (including medical devices and combo products).
Education
Lean in Services
Warsaw School of Economics
01.2018
Pharmacist
Warsaw Medical University
01.1998
Skills
- Area
- Detail
- EMQA & Compliance
- EU GMP, ICH Guidelines, GDPR, FDA, ISO 9001, ISO 13485
- External Partner Mgmt
- Primary Quality Contact for external sites, Supplier Qualification, Quality Agreements, Audits
- Quality Systems
- Change Control, Deviations, Quality Incidents, Complaints handling
- Regulatory Oversight
- Batch Review/Release, Coordination, Implementation, Vigilance Oversight
- Software Systems
- TrackWise, Veeva, CRM, MS Project, Share Point, Visio
- Core Competencies
- Effective communication, attention to detail, fast-changing environment, Kaizen philosophy
- Documentation review
- Quality management systems
- Continuous improvement strategies
- Quality training development
- Product inspection techniques
- Technical report writing
- ISO standards
- Cross-functional teamwork
- Quality assurance expertise
- Lean manufacturing principles
- Corrective action implementation
- Regulatory compliance
- Process improvement techniques
- Six sigma methodologies
- Statistical process control
Timeline
Commercial Quality Representative
Ascensia Diabetes Care
09.2023 - Current
Regional GDP Quality Lead EUCAN / QM
Takeda
06.2021 - 07.2023
Responsible Person for GDP, Supply Chain Quality Manager
PF Consumer Healthcare Poland Sp. z o. o. (Pfizer/GSK - project)
12.2019 - 05.2021
Deputy Responsible Person for GDP, QAS
DAMCO Poland (Maersk Group)
06.2016 - 11.2019
Pharmacist
Warsaw Medical University
Lean in Services
Warsaw School of Economics
COURSES Taken
Internal Auditor, Validations and qualifications, Project Management, EU Regulatory Changes for Medical Devices, Pharmacovigilance 2024.
Personal Information
Title: External Manufacturers Quality Assurance Manager (Contract, Remote - Poland)