Quality Manager

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

Direct message the job poster from Harba Solutions Inc.

• 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.
• Monitor quality metrics and drive continuous improvement and risk‑management initiatives.

Operations & Team Management

• Supervise and develop quality staff; guide cross‑functional teams as needed.
• Partner with operations leadership to align resources and meet quality objectives.
• Support training programs and ensure staff maintain compliance with evolving regulations.

Client & Stakeholder Engagement

• Serve as the primary point of contact for client quality requests, reporting, investigations, and CAPA activity.
• Present quality performance to leadership and clients; assist with onboarding new accounts.
• Provide timely responses to routine and non‑routine customer data or support requests.

Environment & Physical Expectations

• Work within temperature‑controlled warehouse areas.
• Perform occasional physical tasks such as bending, stooping, and lifting up to 50 lbs.

Qualifications

• Bachelor’s degree in a STEM field preferred.
• 7–10 years of experience in GMP‑regulated quality operations.
• Strong knowledge of GMP/GDP and relevant regulations (e.g., FDA, EU guidelines, USP).
• Effective leadership, communication, analytical, and organizational skills.
• Ability to collaborate across teams and proactively address compliance risks.

Seniority Level

• Mid‑Senior level

Employment Type

• Full‑time

Job Function

• Management
• Transportation, Logistics, Supply Chain and Storage and Pharmaceutical Manufacturing

Benefits

• Medical insurance
• Vision insurance
• 401(k)