Anette Yan Marcussen

Managing Consultant, GMP & Compliance

The pharma industry is about to undergo big changes to succeed with innovation, big data use, new technology and overcome the post approval change hurdle

Anette Yan Marcussen has more than 30 years of experience in pharma, both in production and quality. She has a background as M.Sc. Pharmacy and before that as Pharmakonom. She possesses profound and proven leadership and management skills as well as in-depth knowledge of GMP, quality assurance, quality control, aseptic production and quality intelligence.

Anette has worked with strategic development and she has driven international projects of strategic importance. She has built a strong business understanding via her roles as employee-selected member of the Board of DAKO A/S and as joint owner of a contractor company.

Anette Yan Marcussen is actively involved in international cooperation as member of the Regulatory and Quality Advisory Board in PDA (Parenteral Drug Association). 

What's your view on the industry?

"The pharma industry is about to undergo big changes to succeed with innovation, big data use, new technology and overcome the post approval change hurdle.

This can be done by close cooperation between regulatory authorities and pharma companies. I think it will be very important to work together as a team with the benefit for the patient in focus."

Why do you work in this business?

"I work in the pharma industry, because I want to contribute to innovation and bringing new drugs to the market for the benefit for the patients. To ensure this, it is very important to guard the license to operate by complying to authority regulations. The pharmaceutical quality system (PQS) is key to compliance and to be able to have flexible and agile company. Therefore it is crucial to simplify the PQS and optimize the way we work."

Connect on LinkedIn

 

Expert in

  • cGMP
  • GMP strategy development
  • Regulatory compliance and intelligence
  • Quality assurance
  • Process validation
  • ASTM E2500
  • Science and risk assessment / quality risk management
  • Project management / project quality management
  • Pharmaceutical quality system 
  • Inspection
  • Audit
  • Compliance training

Recording: Manage the challenges of pharma 4.0

Control strategy is hot right now - it's a requirement, and it's good business. It is also a focus point for the FDA, issuing 5 warning letters in August and September alone. Get up to speed on control strategy with this webinar.

Download the recording

Explore our services and projects

Services

Services

Dig deeper into NNE's end-to-end engineering and consulting services, tailored to the highly GMP-regulated pharmaceutical industry.

Read more
Projects

Projects

Browse our cases based on technology and geography.

See all our featured projects