Regulatory Affairs + Quality Expertise Required:

Required Experience

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

Key skills expected:

• Management of client specific procedures and NC /CAPA on the programs
• Trainer of OPS staff on Quality process (e.g. NC/CAPA)
• Writing of procedure, process mapping, gap analysis
• Support client 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