Craig Wylie

Managing Partner

Head of Arthur D. Little USA

With 30 years of working in the life sciences industry, Craig focuses on the effective delivery of quality and regulatory compliance in the highly regulated life sciences environment.

Education

Stirling University
BSc Computing Science and Management Science

Past Experience

PA Consulting Inc.
Partner
KPMG
Director

Craig is a Partner at Arthur D. Little, based in Boston, and a member of our global Healthcare & Life Sciences Practice.
Craig’s work includes Quality and Regulatory Operations, Clinical Trial Operational Effectiveness and Manufacturing Compliance, in particular supporting the integration of quality systems post merger, the resolution of audit and inspection findings and process improvement and simplification.

 

Craig has a background in Quality Operations, IT and Clinical Development, and focuses on pharmaceutical and medical device companies helping to ensure the effective implementation of quality and regulatory compliance within this highly regulated environment.

 

Craig has worked with many of the world’s largest Life Sciences firms on aspects of their quality and regulatory environments; this has included work on remediation of warning letters and consent decrees.

 

Craig strongly believes that effective quality management should be an enabler of value within the organization, not a burden. Effective quality and compliance systems guide thinking without stifling innovation.

 

Prior to Arthur D. Little, Craig was a Partner at PA Consulting in the UK and the US, where he led the global quality and regulatory team.

Managing competition, price and access
High medicine prices impose a burden on national healthcare systems, where pharmaceuticals account for a significant share of spending, especially for countries in the early stages of maturity in the pharma sector. Competition authorities have expressed concerns that access to affordable, innovative drugs may be at risk due to high prices, market withdrawals or other business strategies, along with national governments’ limited bargaining power against pharma companies.

Craig is a Partner at Arthur D. Little, based in Boston, and a member of our global Healthcare & Life Sciences Practice.
Craig’s work includes Quality and Regulatory Operations, Clinical Trial Operational Effectiveness and Manufacturing Compliance, in particular supporting the integration of quality systems post merger, the resolution of audit and inspection findings and process improvement and simplification.

 

Craig has a background in Quality Operations, IT and Clinical Development, and focuses on pharmaceutical and medical device companies helping to ensure the effective implementation of quality and regulatory compliance within this highly regulated environment.

 

Craig has worked with many of the world’s largest Life Sciences firms on aspects of their quality and regulatory environments; this has included work on remediation of warning letters and consent decrees.

 

Craig strongly believes that effective quality management should be an enabler of value within the organization, not a burden. Effective quality and compliance systems guide thinking without stifling innovation.

 

Prior to Arthur D. Little, Craig was a Partner at PA Consulting in the UK and the US, where he led the global quality and regulatory team.

Managing competition, price and access
High medicine prices impose a burden on national healthcare systems, where pharmaceuticals account for a significant share of spending, especially for countries in the early stages of maturity in the pharma sector. Competition authorities have expressed concerns that access to affordable, innovative drugs may be at risk due to high prices, market withdrawals or other business strategies, along with national governments’ limited bargaining power against pharma companies.

More About Craig
  • Stirling University
    BSc Computing Science and Management Science
  • PA Consulting Inc.
    Partner
  • KPMG
    Director