Compliance Officer – US Market

Position : Compliance Officer – US Market

Location : Remote — must maintain at least 3 hours daily overlap with U.S. Eastern Time (GMT-4 / -5)

Type : Contract

About the Company

Bridge Business Support Services is leading the delivery of a cutting-edge, FDA-cGMP artemisinin manufacturing line -combining continuous photochemistry, crystallization, and solvent recovery at industrial scale.

Responsibilities :

• Ensure all engineering, procurement, and pilot operations comply with US FDA cGMP, 21 CFR Part 11, ICH guidelines.
• Develop and maintain compliance frameworks for documentation, vendor qualification, audits.
• Review engineering documents (PFDs, P&IDs, equipment datasheets) for regulatory alignment.
• Prepare and support qualification protocols (IQ / OQ / PQ) for equipment and systems.
• Coordinate with vendors and internal teams to ensure regulatory-ready procurement & installation.
• Support preparation of regulatory submissions (DMFs, CMC sections).
• Conduct internal audits and prepare teams for external audits (FDA, clients).

Qualifications & Skills :

What We Offer