More jobs:
Quality Manager
Job in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-06-18
Listing for:
Harba Solutions Inc.
Full Time
position Listed on 2026-06-18
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
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.
- 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.
- 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.
- Work within temperature‑controlled warehouse areas.
- Perform occasional physical tasks such as bending, stooping, and lifting up to 50 lbs.
- 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.
- Mid‑Senior level
- Full‑time
- Management
- Transportation, Logistics, Supply Chain and Storage and Pharmaceutical Manufacturing
- Medical insurance
- Vision insurance
- 401(k)
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