Elena Savoia
Bologna
Summary
Experienced Quality leader with a strong background in supplier quality and regulatory frameworks, poised to transition into a strategic role in Laboratory Regulatory Intelligence. Proven ability to guide cross-functional teams, align laboratory operations with evolving regulatory landscapes, and support global compliance initiatives across diverse product categories.
Overview
6
6
years of professional experience
Work History
Lead - Supplier Quality (Supply&Customer Service Quality)
Philip Morris Manufacturing & Technology Bologna S.p.A.
08.2025 - Current
- Leading the implementation of a risk-based qualification framework for third-party Warehouses, Logistics Providers, and Customer Service Centers, aimed at ensuring regulatory compliance and service quality.
- Developing a strategic model for Quality Governance and Oversight of market-facing third parties, with a focus on aligning warehousing, logistics, and customer service operations with PMI's regulatory and business standards.
Supplier Quality Lead (Supplier&Partnership)
Philip Morris Manufacturing & Technology Bologna S.p.A.
06.2023 - 08.2025
- Led the qualification of GxP suppliers through a risk-based approach, ensuring service quality and regulatory compliance with global standards (FDA, ICH, GLP, GCP, ISO 17025), PMI quality systems, and contractual obligations—fully aligned with corporate strategy.
- Built and nurtured strategic supplier partnerships , fostering a collaborative environment that enabled continuous improvement and supported long-term quality objectives across the organization.
- Monitored supplier performance using predefined KPIs and actively managed quality processes including Change Control, Non-Conformities, CAPAs, and Complaints to ensure sustained compliance and operational excellence.
- Contributed to the development and maintenance of Supplier Quality Management documentation , ensuring inspection readiness, traceability, and seamless integration within PMI's Quality Management System.
- Provided guidance on quality and regulatory requirements to internal stakeholders; supporting quality improvement plans and actively participating in cross-functional projects to deliver strategic input in the area of supplier quality.
- Enabled cross-functional alignment by integrating laboratory and regulatory requirements into core business processes, supporting compliance and innovation across product categories.
- Actively participated in Category Quality Risk Management project , contributing to the development of a business model for escalation and mitigation of L3 - L4 risks across product categories, enhancing strategic decision-making and regulatory preparedness.
QC Chemical Analyst
BSP Pharmaceuticals
08.2021 - 06.2023
- Performed in-process and release testing of anticancer and cytotoxic drugs within a regulated laboratory environment, ensuring accuracy, data integrity, and full compliance with cGMP standards.
- Applied strong cGMP knowledge in a pharmaceutical Quality Control setting, supporting regulatory compliance and data integrity.
- Executed advanced analytical techniques including HPLC/UHPLC, GC, Karl Fischer titration, UV-Vis spectroscopy, osmolality, turbidity, and sub-visible particle testing, contributing to robust product evaluation and regulatory compliance.
- Utilized laboratory software systems such as Empower 3, ChemStation, SamplerSight, UV WinLab ES, and LIMS to ensure efficient data acquisition, traceability, and audit readiness.
- Demonstrated critical thinking in interpreting analytical results, identifying Out-of-Trend (OOT) and Out-of-Specification (OOS) data, and supporting root cause investigations.
- Maintained compliant laboratory documentation , ensuring traceability and alignment with regulatory and internal standards.
- Supported high-throughput operations , including 24/7 shift work, to ensure business continuity and timely testing in a fast-paced environment.
- Developed strong interpersonal and communication skills , contributing to effective teamwork and the achievement of quality and compliance objectives.
QC Analyst
Aptuit (Oxford) LTD
01.2020 - 06.2021
- Conducted analytical testing of raw materials, intermediates, final products, and cleaning samples using validated, regulatory-compliant methods, ensuring product quality and cGMP regulatory alignment.
- Applied advanced analytical techniques including HPLC, GC, ¹H-NMR, Karl Fischer titration, and XRD to ensure product quality and consistency.
- Reinforced adherence to cGMP and ALCOA principles , ensuring data integrity, traceability, and inspection readiness in a highly regulated laboratory environment.
- Demonstrated strong time management and multitasking skills , consistently meeting deadlines and contributing to operational efficiency in a dynamic, high-throughput setting.
- Operated independently and collaboratively , trained to high operational standards, and actively contributed to team-based quality and compliance goals.
- Collaborated with cross-functional teams to support quality assurance objectives, including chemical inventory management and proper disposal of expired materials to maintain product integrity and regulatory compliance.
Pharmaceutical Operator Specialist
Aptuit (Oxford) LTD
06.2019 - 01.2020
- Operated pilot plant reactors and ancillary equipment in compliance with Best Practice Guidelines (BPGs) and Instruction Operative Procedures (IOPs), ensuring process reliability and consistency in a cGMP regulated environment.
- Maintained high safety and quality standards during cleaning and operational activities, following specific procedures.
- Supported process chemists and management in optimizing Active Pharmaceutical Ingredient (API) development, contributing to process improvement and scale-up activities.
- Strengthened analytical capabilities through hands-on experience with HPLC, Karl Fischer titration, and ¹H-NMR, supporting in-process and final product testing aligned with regulatory expectations.
- Demonstrated strong problem-solving and analytical thinking , addressing complex procedural challenges and ensuring smooth operations under cGMP conditions.
- Gained solid understanding of cGMP and ALCOA principles , reinforcing data integrity, traceability, and compliance across all laboratory and pilot plant activities.
Education
MS - Analytical Bioscience
Birkbeck University of London
01.2019
MS - Pharmaceutical Chemistry and Technology
University of Bari
01.2006
Skills
- Attention to detail
- Critical thinking
- Organization and time management
- Emotional Intelligence
- Cross-functional teamwork
LANGUAGES
Italian: Native Language
English: Advanced Reading, Writing, Listening, Speaking
Accomplishments
Recognized as contributor to the PMI manuscript on the Exposure Study in Japan, to be formally acknowledged in the publication for scientific collaboration.
Timeline
Lead - Supplier Quality (Supply&Customer Service Quality)
Philip Morris Manufacturing & Technology Bologna S.p.A.
08.2025 - Current
Supplier Quality Lead (Supplier&Partnership)
Philip Morris Manufacturing & Technology Bologna S.p.A.
06.2023 - 08.2025
QC Chemical Analyst
BSP Pharmaceuticals
08.2021 - 06.2023
QC Analyst
Aptuit (Oxford) LTD
01.2020 - 06.2021
Pharmaceutical Operator Specialist
Aptuit (Oxford) LTD
06.2019 - 01.2020
MS - Pharmaceutical Chemistry and Technology
University of Bari
MS - Analytical Bioscience
Birkbeck University of London