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Director, Quality Systems & Compliance (Hybrid)
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Full-time
- Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.
- Oversees the management of the Quality Systems & Compliance team supporting product quality complaints, post market surveillance, Annual Product Quality Reports, field alerts, recalls, internal audit program, inspection readiness and external audits / inspections, Compliance Surveillance, Quality metrics, and Quality Management Review (QMR).
- Process owner for Quality Systems Management processes including Quality Events, Deviation, Non-Conformance, CAPA, Change Control, Complaint Investigations, Document Control, and Training.
- Provide project and Subject Matter Expert support for all activities involving modifications, upgrades and or business process changes related to Quality Systems tools and applications.
- Responsible for inspection readiness and manage regulatory inspection processes relating to cGMP including, but not limited to, FDA, MHRA, EMA, Health Canada, and Notified Body, across multiple sites.
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