Open to opportunities

Diana Russo

@dianarusso

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Quality assurance leader specializing in GMP investigations and QMS.

Italy

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What I'm looking for

I seek a senior QA role leading investigations, QMS improvement and CSV projects in a collaborative, regulated environment with opportunities for impact and global coordination.

I am a result-driven Quality Assurance professional with over 10 years of experience in GMP-regulated pharmaceutical, medical device, cosmetics and dietary supplement sectors, focused on investigation leadership and QMS management.

At Cooper Consumer Healthcare I lead global quality initiatives and site investigations, driving KPI improvements such as a 50% reduction in common-cause deviations and coordinating a 30-person investigator training effort.

I manage QMS activities including SOP rationalization, change controls and CSV projects (CFR 21 Part 11), having led eQMS design/validation and system migrations while reducing SOP redundancy by 20%.

I am a qualified internal/external auditor across pharma (cGMP), ISO 13485/MDR, IFS, FDA CFR 21 Part 111 and ISO 22716, and hold certifications including Lean Six Sigma Yellow Belt, HACCP and CSV training.

Experience

Work history, roles, and key accomplishments

Current

Teaching Professional

Current

Postgraduate Course in Regulatory Affairs

Jul 2020 - Present (5 years 3 months)

Deliver course modules on medical device regulation (ISO 13485, MDR) for postgraduate students, providing regulatory guidance and practical compliance examples.

Regulatory Affairs ISO 13485)MDR Curriculum Development Teaching ISO 13485

Current

Quality Assurance Specialist

Current

Cooper Consumer Healthcare Italia

Jul 2015 - Present (10 years 3 months)

Led global site quality activities including KPI reporting and root-cause investigations, reducing common-cause deviations by 50% and consolidating SOPs to cut redundancy by 20%. Managed QMS, CSV projects (CFR21 Part 11) and trained a 30-person investigator network to improve human-error prevention.

Quality Management Root Cause Analysis GMP ISO Auditing Trackwise LIMS CAPA Change Control

Laboratory Technician

University of Milano-Bicocca

Jan 2010 - Sep 2011 (1 year 8 months)

Performed in vitro and biomolecular assays, clinical biochemistry and immunometric testing to support research and lab activities.

Education

Degrees, certifications, and relevant coursework

University of Pavia

Teaching / Professional Instruction, Regulatory Affairs / Medical Devices

2020 -

Teaching professional for a postgraduate course in Regulatory Affairs, delivering a course on Medical Devices regulation including ISO 13485 and MDR.

Università degli Studi di Parma

Professional Qualification (Biologist State Examination, Level A), Biology

Achieved professional qualification as a Biologist by passing the State Examination (Level A), enabling professional practice.

Università Cattolica del Sacro Cuore

Postgraduate Diploma, Food Law / Food Safety

Postgraduate diploma in Food Law applied to Food Safety focusing on regulatory and safety aspects of food and related products.

Università degli Studi di Milano-Bicocca

Master of Science, Biology

Activities and societies: Laboratory technician work in pharmacology (in vivo tests, biomolecular tests, clinical biochemistry, immunometry).

Completed a Master of Science in Biology with coursework and laboratory experience in pharmacology, biomolecular tests, clinical biochemistry, and immunometry.