Job Summary

A biopharmaceutical company has an open position for a Remote Small Molecule Quality Operations Quality Assurance Director or Senior Director.

Must be able to:

• Provide technical quality oversight and support for the small molecules programs
• Provide quality support for all aspects of drug substance process development
• Support regulatory filings and inspections

Qualifications Include:

• Ph.D. in related discipline with 10+ years of pharmaceutical experience or M.S. with 15+ years
• 5+ years of hands-on experience working with Quality Operations providing technical review
• Solid understanding of the principles of chemical development
• Working knowledge of all regulatory guidelines relevant to cGMP work
• Hands on experience in authoring and reviewing sections of CMC modules
• Understanding of GMP requirements/regulations for clinical/commercial CMC drug development