Years of experience: 28

AssistantCustomer ServiceService Quality ManagerProject CoordinatorAdvisorConsulting

Trust Score

Highly reliable; strong professional involvement.

70%
V's Career Path
Site Head of Quality Compliance Dec. 2023 -
Present
Sun PharmaceuticalsSite Head of Quality Compliance
• Successfully hosted FDA (2025) and Health Canada (2024) audits, ensuring compliance with regulatory standards. • Directed inspection readiness and post-market surveillance, enhancing product safety and quality oversight. • Lead Quality Metrics reporting and analysis, and coordinate the Quality Management Review (QMR) process to ensure effective oversight and continuous improvement of site q...
Director of Quality Assurance Compliance & Operations Jul. 2022 -
Aug. 2023
Rentschler BiopharmaDirector of Quality Assurance Compliance & Operations
Milford, Massachusetts, United States• Managed the build-out and daily operations of the new RBMC production facility at Rentschler Milford. • Ensured compliance with the Quality Management System and applicable regulations for Milford operations. • Collaborated with Engineering and Facilities to design a new GMP facility and prepared for audits. • Hosted Audits and inspection for FDA, PMDA as well as internal and client Audits....
Head Of Quality AssuranceSep. 2021 -
Jul. 2022
Northway BiotechHead Of Quality Assurance
Waltham, Massachusetts, United StatesHead of Quality Assurance – Northway Biotech Sep 2021 to current • Responsible to maintain product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods. • maintain collaboration with clients by ...

V's Posts

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    About myself

    A results-driven Quality leader, I align quality assurance with business goals, enhancing regulatory success and operational excellence. Recognized for my transformational leadership, I excel in global compliance, cross-functional alignment, and continuous improvement. I specialize in GMP & GCP, designing risk-based systems and validation strategies, and driving QMS integration with ICH standards.

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    Job Description

    I seek a consulting role in Quality Assurance within the pharmaceutical industry, leveraging my expertise in regulatory compliance and strategic quality management to enhance operational effectiveness and drive continuous improvement.

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    How to contact

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