Regulatory & Quality Compliance Consultant

Regulatory & Quality Compliance Consultant

Regulatory & Quality Compliance Consultant is a domain Expert providing the deep regulatory, operational, and compliance expertise needed to guide customers through digital transformation initiatives using Low-Cod Application solutions (LIMS, eQMS, MES, DMS, EMS). This role ensures that proposed solutions align with GMP, GAMP, and global regulatory expectations while helping clients optimize their quality and manufacturing processes.

They act as the credibility anchor in sales cycles and the compliance authority during implementation.

Key Responsibilities

• Interpret and explain regulatory requirements (GMP, GAMP 5, 21 CFR Part 11, Annex 11, WHO, MHRA, PIC/S).
• Advise clients on best practices for digitalizing quality and manufacturing processes.
• Ensure solution designs meet compliance expectations for audits and inspections.
• Translate pharma workflows into digital work...