Required Experience:

Regulatory Affairs + Quality Expertise Required:

8 + years’ experience within a Quality role in Pharmaceutical industry, previous role or knowledge in RA domain

Key Skills Required:

  • Management of client specific procedures, NC and CAPA for client
  • Trainer of OPS staff on Quality process (e.g. NC/CAPA)
  • Writing of procedure, process mapping, gap analysis
  • Support of GVP audits
  • Ability to lead working group with clients, take minutes on flight, propose solution
  • Client facing to defend PLG process and find compromises

Required Technical Skills:

  • RA background / training
  • Quality assurance specific training
  • Experience in using QMS tools (such as ENNOV, Trackwise, Mastercontrol, Veeva etc)
  • knowledge of methodologies such as ISO 9001 2015 standard, Six Sigma, Lean or CMM
  • Graphical process modeling methods and tools (Visio)

Strong Soft Skills:

  • Partnership mindset
  • Commitment to deadlines
  • Excellent written and oral communication skills
  • Communication with client

Required Education:

Bachelor’s or higher graduate degree in a science related field, or equivalent experience

QPI Expert (RA) – VAF 167

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