Sujitha Muthuswamy
Director, QA Operations (CDMO) | Head of Quality (QMR) | Head of Manufacturing Operations
- Role
- Director, Qa Operations at Catalent
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
About Sujitha Muthuswamy
Proven leadership experience (20+ years) in quality, manufacturing, regulatory and clinical in CDMO/pharmaceutical/ biologics/medical device industry – Canada and USA • Accomplished Quality site head (QMR) for multiple sites in various business segments (Renal therapy, Biosurgery) • Proficient in assessment of quality risks throughout the manufacturing process, integrating global QMS into new manufacturing sites and developing/executing remediation plans • Successful Audit host, direct support (Quality site head, Strategist, SME, Backroom) for over twenty (25) on-site audits (FDA, TÜV SÜD, ANVISA, Korea, Health Canada, Internal Audits, Supplier Audits, UL, Safety audits) • Strong operations leader with a Six Sigma black belt focused on continuous improvement, COGS reduction, compliance to regulations, and achievement of business objectives
Experience
Director, Qa Operations
Aug 2025 — Present · Hanover, MD, US
Responsible Areas: Client QA, QA On The Floor, QA Raw Materials, QA Analytical support, QA Batch Disposition
Education
University of Calicut
Bachelor's degree, B.Sc.
Madurai Kamaraj University
Master's degree - M.Sc.
Kriger Research Centre, ON, CANADA
Diploma
University of Guelph
Ph.D candidate - Research/Teaching Assistant
Rajiv Gandhi Centre for Biotechnology, Kerala, India
Ph.D Candidate - Research assistant
University of Kerala
Bachelor's degree - B.Ed.
Academy of Applied Pharamceutical Sciences
PG Diploma in Regulatory Affairs
University of Kerala
Master's degree - M.Phil
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