Featured Member: Kalene Cohn on HBCU CONNECT!

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Q&A With Kalene Cohn

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Kalene Cohn
Director of Global Quality and Compliance, Nobel Link
Location: bristol, PA United States
Joined: Aug 6th, 2025

About (request update)

Education (request update)

La Salle Univ class of 2018

Undergrad Major: Bioengineering

Experience

I currently work with Nobel Link as Director of Global Quality and Compliance
I have years of experience working in the Research & Development industry.

Director, Global Quality & Compliance | Nobel Link
From May 2024 to Current • 2 year(s)
Direct global Quality Management Systems for AI, cloud, and data solutions to meet Fortune 500 pharmaceutical client regulatory requirements. Lead cross-functional collaboration and oversee audits and continuous improvement initiatives.

Senior Manager | Voyant Beauty
From September 2024 to December 2024 • 0 year(s)
Oversaw site quality and compliance strategy across 24/7 manufacturing operations. Led QMS continuity during site-scale down and achieved zero-finding regulatory audit.

Operations Manager | Merck
From November 2022 to May 2024 • 2 year(s)
Served as Business Process Owner for global QMS processes including deviation management and CAPA. Directed vaccine manufacturing operations overseeing 30+ staff and served as audit SME.

Quality Specialist | Merck
From August 2021 to November 2022 • 1 year(s)
Released 78 batches to market with 100% compliance. Managed deviation and CAPA life cycle within TrackWise and led eQMS platform optimization.

Scientist II | Merck
From August 2020 to August 2021 • 1 year(s)
Conducted GMP batch record reviews and root cause investigations. Resolved critical GMP deviations, salvaging 5 batches and preventing ~$500K in losses.

Senior Pharmacy Technician | Rite Aid & Walgreens
From May 2013 to November 2020 • 7 year(s)
Ensured accurate medication dispensing and compliance with pharmacy regulations. Played key role in public health initiatives, improving vaccination uptake by 60%.

Media Preparation Scientist | Bristol Myers Squibb
From May 2019 to August 2020 • 1 year(s)
Supported tech transfer and upstream media formulation for biologics manufacturing. Maintained compliance with GMP documentation and aseptic technique requirements.

QA Specialist & QC Microbiologist | AstraZeneca
From January 2018 to May 2019 • 1 year(s)
Conducted environmental monitoring and cleanroom sampling in Grade A/B spaces. Supported PAI readiness and contributed to CAPA tracking for microbiological issues.

Project Manager | Enactus
From August 2013 to May 2018 • 5 year(s)
Led 15-person team through award-winning sustainability projects, achieving Johnson & Johnson Award. Advanced to national competition top 100 through strategic planning.

Student Researcher | La Salle University
From August 2015 to December 2016 • 1 year(s)
Conducted biologics research with focus on CHO-based systems and GMP scale-up readiness. Gained foundational expertise in experimental design and data integrity.

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