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Harba Solutions Inc.

Quality Manager

Harba Solutions Inc., Indianapolis, Indiana, us, 46262

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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)

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