Senior GMP Quality & Compliance Lead

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading life-science solutions provider in Indianapolis is looking for a Quality Operations lead. The role involves overseeing quality systems, managing compliance with regulatory standards, and driving continuous improvement initiatives. The ideal candidate will have a Bachelor’s degree in a STEM field and 7–10 years of experience with strong leadership and communication skills. This full-time position offers benefits including medical and vision insurance, as well as a 401(k).

Qualifications

• 7–10 years of experience in GMP-regulated quality operations.
• Strong knowledge of GMP/GDP and relevant regulations (e.g., FDA, EU guidelines, USP).

Responsibilities

• Lead the quality function for life-science warehouse and distribution operations.
• Oversee quality systems, SOPs, policies, and compliance with GxP requirements.
• Manage internal/external audits, inspections, and regulatory interactions.

Skills

Leadership

Communication

Analytical skills

Organizational skills

Collaboration

Education

Bachelor’s degree in a STEM field

Job description

A leading life-science solutions provider in Indianapolis is looking for a Quality Operations lead. The role involves overseeing quality systems, managing compliance with regulatory standards, and driving continuous improvement initiatives. The ideal candidate will have a Bachelor’s degree in a STEM field and 7–10 years of experience with strong leadership and communication skills. This full-time position offers benefits including medical and vision insurance, as well as a 401(k).