Act as principal point of contact for assigned Contract Manufacturing Organisations (CMOs), establishing effective ways of working, governance structures and communication channels aligned with GSK's differentiated oversight model.
Lead negotiations and implementation of Quality Agreements (QAA) with CMOs and drive ongoing adherence to contractual obligations (QAA / MSA / SLA elements), ensuring alignment with robust and compliant Quality Systems.
Own supplier performance management through establishment, monitoring and continuous review of KPIs defined by contractual and business requirements, driving measurable improvements in quality, compliance and supply reliability.
Ensure seamless regulatory and quality information flow between GSK releasing sites and CMOs, in line with Quality Agreements and regulatory expectations.
Apply robust supplier risk management using approved risk tools, identifying, assessing and mitigating risks to product quality and security of supply in line with EM-SM risk processes.
Escalate critical quality, compliance or supply risks via GSK Risk Management Systems (RMS) to Quality Council, Local Incident Committee (LIC) and Product Incident Review Committee (PIRC), ensuring timely resolution and leadership visibility.
Conduct purposeful GEMBA visits in accordance with the GEMBA Plan to assess shop-floor execution, quality culture and operational robustness at CMOs.
Lead and coordinate cross-functional, matrixed collaboration with internal GSK functions (PQTS+, EM Procurement, Supply, Regulatory) to proactively identify and resolve quality, compliance, and supply-chain risks, ensuring security of product supply.
Collaborate closely with CMOs to ensure manufacturing and quality systems (batch records, deviations, change controls, validations, investigations) are robust, compliant, and continuously improved.
Drive periodic CMO Quality System reviews to complement audit activities, ensuring sustained compliance and long-term supplier capability.
Lead root-cause analyses and remedial action planning, ensuring effective implementation and verification of corrective actions.
Contribute to regulatory intelligence and strategy, supporting scientific and technical discussions impacting GSK products and ensuring learnings are translated into actionable improvement plans.
Facilitate CAPA development and closure for CMO audit observations, ensuring timely, effective, and sustainable remediation.
Support security of supply through close oversight of product disposition, issue resolution, and coordination with supply-chain stakeholders.
QUALITY ASSURANCE AND DOCUMENTATION COORDINATOR
ROCKWOOL GLOBAL BUSINESS SERVICE CENTER
01.2022 - 09.2022
Led engineering project management for new machine installations and production line modifications, acting as a key interface between internal teams and external suppliers.
Supported end-to-end project execution, from specification and tendering through installation, validation, and final handover, in collaboration with local and international stakeholders.
Owned machine safety and compliance engineering, ensuring equipment integration met regulatory, EHS, and internal quality standards.
Coordinated cross-functional risk assessments (including supplier-provided equipment), identifying, mitigating, and tracking risks throughout the project lifecycle.
Led and supported audits to ensure safe and compliant integration of equipment into factory operations.
Ensured timely preparation, review, and approval of project and quality documentation, maintaining alignment with contractual and regulatory requirements.
Acted as a primary coordination point between engineers, project managers, equipment suppliers, and customers, ensuring clarity of requirements, expectations, and deliverables.
Oversaw CE marking certification for production lines (greenfield, brownfield, and modernized installations), ensuring full compliance with applicable directives and standards.
Reviewed and approved tender specifications, ensuring technical, quality, safety, and compliance requirements were clearly defined and contractually embedded.
Supported supplier performance and compliance oversight during installation and commissioning phases, driving issue resolution and corrective actions where required.
Quality Engineer
Beiersdorf Manufacturing Hamburg GmbH
11.2020 - 12.2021
Led factory expansion and production line transfer projects from another location, ensuring full compliance with IQ/OQ/PQ validation requirements and internal quality standards.
Acted as a key interface between internal project teams and external suppliers, coordinating activities to ensure smooth transfer, installation, and qualification of equipment.
Managed and delegated tasks within cross-functional project teams, ensuring timely delivery of project milestones in line with quality, safety, and compliance expectations.
Led quality activities within capital and transfer projects, ensuring adherence to GMP, validation requirements, and internal procedures.
Delivered factory improvement and automation initiatives (cobots, online printers, production line automation, vision systems), supporting operational robustness, efficiency, and long-term sustainability.
Conducted Factory Acceptance Tests (FATs) at supplier sites, verifying equipment performance, quality, and compliance prior to delivery and installation.
Created, reviewed, and approved project and quality documentation (validation plans, protocols, reports, risk assessments) required to support compliant project execution.
Collaborated closely with suppliers to investigate and resolve serious quality issues, driving root-cause analysis, corrective actions, and verification of effectiveness.
Supported risk identification and mitigation during line transfers and equipment implementation, ensuring continuity of production and minimization of operational disruption.
SUPPLIER QUALITY ASSURANCE
Unilever
04.2019 - 11.2020
Owned supplier complaint management, leading investigations with suppliers and overseeing implementation and effectiveness of corrective and preventive actions (CAPAs).
Acted as a key interface to external suppliers, driving structured problem-solving, root-cause analysis, and sustainable resolution of quality issues.
Prevented recurrence of quality incidents through trend analysis, risk-based actions, and proactive supplier engagement.
Led and delivered supplier-focused quality improvement projects within factory operations, improving process robustness and product compliance.
Executed continuous improvement initiatives using WCM methodology, embedding standardized problem-solving and performance discipline.
Recruited, coached, and temporarily managed team members, ensuring continuity of supplier oversight and delivery of quality objectives.
Developed and delivered GMP and GHP training programs for employees and subcontractors, strengthening quality culture and compliance across internal and external operations.
Implemented and enforced GMP/GHP standards, ensuring consistent application across suppliers and internal stakeholders.
Supported digitalization of supplier quality processes through implementation of Veeva Systems for complaint registration, tracking, and performance visibility.
Provided supplier performance data and insights to support management reviews, escalation decisions, and continuous improvement planning.
SENIOR QUALITY CONTROLLER
WSAudiology
05.2012 - 03.2019
Ensured consistent quality of processes and products, supporting stable operations and reliable supplier and internal performance.
Analyzed non-conformities and performance deviations, identifying root causes and coordinating corrective and preventive actions.
Actively participated in internal and external audits, supporting compliance assessments and follow-up actions.
Initiated, planned, and coordinated corrective and preventive actions (CAPA) to address quality issues and prevent recurrence.
Drove continuous improvement of the quality management system, strengthening process robustness and compliance maturity.
Supported implementation of Lean methodologies (5S, One Piece Flow), contributing to operational efficiency, standardization, and waste reduction.
Education
Master of Science - PHYSICS
UNIVERSITY OF ADAM MICKIEWICZ IN POZNAN
Post Graduated Diploma - Quality Management - Lean Manufacturing
POZNAN UNIVERSITY OF TECHNOLOGY
Skills
Supplier Quality Risk Management
FMEA
SAP
WCM
GMP/GHP/GDP
Lean Tools
Excel
POWER BI (Performance dashboards)
KPI Management
Performance Reviews
Problem Solving
Audits
Continuous Improvement
Supplier performance management
Project management
Cross-functional collaboration
Root-cause analysis
TRAINING / COURSES
Artificial Intelligence: Future starts today - Digital University
Process Mapping and Flowcharts Certification (Accredited) - Advanced Innovation Group Pro Excellence (AIGPE™)
Machine and Device Operation in the Work Environment - EMT
Systems FMEA Specialist Certification (Accredited) - Advanced Innovation Group Pro Excellence (AIGPE™)
Six sigma: analyze, improve, control - Technical University of Munich
Internal Auditor ISO 9001 - POZNAN UNIVERSITY OF TECHNOLOGY
Lean Kaizen Manager - POZNAN UNIVERSITY OF TECHNOLOGY
Websites, Portfolios and Profiles
https://www.linkedin.com/in/daria-s-10ab49158/
Timeline
External Supply Quality Lead
GSK
09.2022 - Current
QUALITY ASSURANCE AND DOCUMENTATION COORDINATOR
ROCKWOOL GLOBAL BUSINESS SERVICE CENTER
01.2022 - 09.2022
Quality Engineer
Beiersdorf Manufacturing Hamburg GmbH
11.2020 - 12.2021
SUPPLIER QUALITY ASSURANCE
Unilever
04.2019 - 11.2020
SENIOR QUALITY CONTROLLER
WSAudiology
05.2012 - 03.2019
Master of Science - PHYSICS
UNIVERSITY OF ADAM MICKIEWICZ IN POZNAN
Post Graduated Diploma - Quality Management - Lean Manufacturing
<ul><li>Completed PPAPs</li><li>Corrective actions and reports if needed</li><li>Made sure all documented information was up to date</li><li>Was in charge of Quality department for 2 facilities Michigan and North Carolina</li><li>Made sure all quality guidelines are being followed throughout the company</li><li>In charge of all inspectors to make sure all guidelines were being followed</li><li>Certified lead auditor for ISO 9001:2015</li><li>Issued Corrective Actions and discrepancy reports if needed</li><li>Setup and performed calibration schedules</li><li>Controlled external quality failures by addressing the root cause, using a 5 why system</li></ul> at Hydra-Flex Corporation<ul><li>Completed PPAPs</li><li>Corrective actions and reports if needed</li><li>Made sure all documented information was up to date</li><li>Was in charge of Quality department for 2 facilities Michigan and North Carolina</li><li>Made sure all quality guidelines are being followed throughout the company</li><li>In charge of all inspectors to make sure all guidelines were being followed</li><li>Certified lead auditor for ISO 9001:2015</li><li>Issued Corrective Actions and discrepancy reports if needed</li><li>Setup and performed calibration schedules</li><li>Controlled external quality failures by addressing the root cause, using a 5 why system</li></ul> at Hydra-Flex Corporation