What are the responsibilities and job description for the Quality Manager position at Harba Solutions Inc.?
Responsibilities
Quality Leadership & Compliance
- 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.