Joy Ghosh
Proven cross-functional strategic leader in life sciences and biotech industry, driving BD, optimizing HT operations, and ensuring QA excellence to deliver innovative solutions enhancing patient outcomes.
- Role
- Director of Quality & Regulatory Affairs at Sklar Instruments
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Joy Ghosh
Versatile and results-driven life sciences leader with a proven track record across Quality Assurance, Scientific and Technical Operations, Business Development, Strategic Marketing, and overall site and program management. I bring a unique blend of regulatory expertise, deep technical knowledge, and commercial acumen to every role delivering growth, compliance, and innovation in equal measure.With over 15 years of experience in biopharma, biotech, and CDMO settings, I’ve successfully led GMP and ISO-compliant Quality Systems, scaled production operations, built and expanded scientific service portfolios, and forged impactful partnerships through consultative, science-driven business development. My career has been defined by building and leading high-performing cross-functional teams and creating strategies that align operational excellence with business growth.A born leader with a hands-on, people-first approach, I take pride in mentoring teams, breaking silos, and encouraging collaboration across quality, R&D, manufacturing, and commercial teams. I’m passionate about transforming vision into reality and driving sustainable success through purpose, precision, and partnership.Key expertise: Cross functional Leadership, Strategic marketing, Business Development, Regulatory Affairs, QA, QMS, HT Manufacturing, Research & Product Development, Technical Support, Project Management, Business Operations in Biotechnology/ Life Sciences/ Medical Device industries - overall site management with P/L responsibilities. Background: Advanced Therapies, Molecular Diagnostics, IVD, Molecular Biology, Gene Synthesis, Plasmid Mfg, Microbial Biotechnology, Infectious Diseases, Medical Device, Clinical Proficiency, Food, Beverage & Industrial Microbiology. OSHA, IATA, IVD, cGMP, GDP and GLP knowledge and experiences.Regulatory experiences including ISO 13485, 17025, 17034, 14971, 9001, USP, and FDA 21 CFR Part 820, 210, 211.
Experience
Director of Quality & Regulatory Affairs
Dec 2025 — Present · Philadelphia, PA, US
Education
University of Calcutta
B.Sc, Zoology (Honors)
National Institute of Information Technology
Post-Graduate Diploma, Network centered Software Engineering
University of Calcutta
M.Sc, Zoology (Neuroendocrinology)
University of Kentucky
Ph.D., Molecular and Cell Biology
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