Amrita Aiden
Director, Global Quality and Compliance, MMD at Merck
Director, Global QMS at Merck
A highly motivated quality professional with over 20 years of experience in pharmaceutical R&D, commercial manufacturing, and regulatory approval. Expertise in US and EU cGMP inspection requirements, implementing and managing quality management systems, and driving continuous improvement in partnership with multidisciplinary teams. Strong background in regulatory compliance, CAPA and compliance management.

Technical Skills:
GMP manufacturing
FDA and Consent Decree Auditing
Quality Risk Management 
Continuous Process Improvement
Regulatory Compliance
Quality Agreements and Technology Transfer
Project Management

Professional Certification:
Certified Quality Auditor ( ASQ)
Certified Lean Leader
Certified Six Sigma Green Belt (ASQ)
RAPS certificate in Pharmaceuticals
Merck
https://www.linkedin.com/company/merck
https://media-exp1.licdn.com/dms/image/C4E0BAQHpUIrEjGJBhw/company-logo_100_100/0/1625578149162?e=1655942400&v=beta&t=KwCRwaixhFfooYBhRZQLwNUKQn1BGWIujQ4BAoFzCNs
Director, Global Quality and Compliance, MMD
Masters
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The City University of New York
https://www.linkedin.com/school/city-university-of-new-york/
Bsc Hons
https://media-exp1.licdn.com/dms/image/C4E0BAQHtiWyZ6RNLjg/company-logo_100_100/0/1519866603659?e=1655942400&v=beta&t=nneasWy5Gsq849W8pHwKKE9tVGjYOfLH9s3zthlFk70
Panjab University
https://www.linkedin.com/school/panjab-university/
Merck
Quality Risk Management Facilitator
American Society of Quality
Certified Six Sigma Green Belt
Sanofi OE
Lean Leader Certification
Regulatory Affairs Professionals Society (RAPS)
RAPS Certificate in Pharmaceuticals
ASQ
Certified Quality Auditor
ASQ - World Headquarters
credentials.asq.org
34833466
ASQ Certified Quality Auditor
https://credentials.asq.org/1b645a03-69ef-4d52-b55a-48b831425c89
Toastmasters International
Founder and President of Frontline Speakers Toastmasters Club
Merck QRM Center of Excellence
Quality Risk Management
https://www.linkedin.com/in/garyknapick
Greater Boston
Gary Knapick PE
Director, Global Maintenance & Reliability (Biologics Operating Unit) at Takeda
https://www.linkedin.com/in/rajesh-sharma-0670477
Cary, NC
Rajesh Sharma
Director of Biologicals External Manufacturing at Merck
https://www.linkedin.com/in/elizabeth-basulto-jasso-528b0911
Morristown, NJ
Elizabeth Basulto Jasso
Experienced Leader in Biopharmaceutical global industries across the Product Life Cycle Management
https://www.linkedin.com/in/chris-milano-phd-b273153a
Doylestown, PA
Chris Milano PhD
VP Quality Assurance | Track record of driving change and operational excellence across organizations.
https://www.linkedin.com/in/lynnkelleher
New City, NY
Lynn Kelleher
Sr. Director QA at Pharmacosmos Therapeutics Inc.
https://www.linkedin.com/in/ajay-gupta-082b5156
United States
Ajay Gupta
Director, Clinical Supplies, Merck
https://www.linkedin.com/in/jess-hundal-90751a107
New York City Metropolitan Area
Jess Hundal
Executive Director at Kite Pharma
https://ie.linkedin.com/in/donal-kelleher-39950719
Ireland
Donal Kelleher
Executive Director, Sterile External Manufacturing Operations at MSD
https://www.linkedin.com/in/davidege
New York City Metropolitan Area
David Ege
EVP Bioprocess & Manufacturing, Chief Technology Officer at Seres Therapeutics
https://www.linkedin.com/in/nanda-kumar-7a97bb6
Fulshear, TX
Nanda Kumar
Executive Director - Public Cloud & Platforms Engineering at Verizon
https://ch.linkedin.com/in/graeme-lowe-71a01114
Le Landeron
Graeme Lowe
Head of Quality, Internal Manufacturing Pharma
https://www.linkedin.com/in/katherinenash
Boston, MA
Katherine Nash
Lead Business Intelligence Analyst at Acquia
https://www.linkedin.com/in/drewcervantes27
San Antonio, TX
Andrew “Drew” Cervantes
BS Cloud Computing
https://www.linkedin.com/in/hayleyfrancesbuckner
Irvine, CA
Hayley Buckner
Chief of Staff - Worldwide Consumer Channel Sales & Marketing at Microsoft
https://www.linkedin.com/in/kathryn-aarons-7a241a197
San Francisco Bay Area
Kathryn Aarons
Office Manager at Zuora
https://www.linkedin.com/in/jaimesantanaaponte
Round Lake, IL
Jaime Santana
Executive Director, Global Quality Compliance at Akorn, Inc
https://www.linkedin.com/in/zahid-muhammad-0625241a
Greater Philadelphia
Zahid Muhammad
Director, Computer System Validation, Quality Systems and Head of Compliance at Merck
https://www.linkedin.com/in/francisco-vazquez-6038882
San Antonio, TX
Francisco Vazquez
Head of Quality- SATX, VIATRIS
https://www.linkedin.com/in/tracyguldan
United States
Tracy Guldan
Senior Director, Product Quality Compliance at NOVAVAX INC
Cynthia Gronostajski
      
          



            
              
        
              
  

    
        Amrita, is a very detailed oriented individual who always has a good understanding of projects she works on. Very easy to work with, gets along with everyone and most important always gets the job done. Kirsten Nagashima
      
          



            
              
        
              
  

    
        Amrita is a detail oriented individual with any project.  I worked closely with Amrita on a vaccine project which required great technical skills in protein purification and measuring antibody binding.  She can easily grasp new concepts and was an important part of our team.