Instructor

Nina Bjork

Nina Bjork is passionate about helping organizations realise and overcome the barriers to sustainable long-term growth. She brings over 20 years’ experience across a range of pharmaceutical companies and from the Regulatory Authorities. She has worked in small, medium and large pharma biotech companies across the product lifecycle for a wide range of dosage forms. She has held roles in development, site leadership and QA that have been responsible for fully outsourced and on site operations, supply chains, process development, validation, engineering and manufacturing.

She has senior operational and corporate-level experience in quality assurance and has led multinational companies in strategic projects associated with:

  • Major culture change to prepare for commercial manufacturing, accelerate output of plant, cost of quality, employee attitude to “mistakes” and how to integrate quality culture
  • Crisis management including handling of regulatory authority actions, multinational recall, bacterial and fungal contamination in plant, etc.
  • Installation, monitoring and periodic effectiveness checks on site or company quality management systems
  • Inspection readiness and remediation (Europe, Brazil, Turkey, Russia, Japan, Canada, and US FDA)
  • Paradigm shifts including downsizing, upsizing, mergers and acquisitions
  • QP development, training, mentoring and resource management
  • Lean projects in QC laboratories and biotech facilities (upstream and downstream)
  • Management review and escalation processes from shop floor to leadership level

Her recognized expertise includes:

  • Quality management systems
  • GMP auditing of facilities and processes
  • Sterile manufacture
  • Biotech products
  • Supply chain
  • Inspection readiness
  • Remediation
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