Senior Quality Manager

Company : Katalyst Healthcares & Life Sciences

Responsibilities:

• Manage daily quality oversight of 3PL providers and ensure compliance with regulatory expectations.
• Maintain and support the Quality Management System (QMS) for distribution operations.
• Prepare and maintain Quality Agreements.
• Handle deviations, CAPAs, change controls, and related documentation.
• Conduct risk assessments and recommend mitigation strategies.
• Maintain KPIs and support Management Review processes.
• Support regulatory inspections, including planning, hosting, and follow-up CAPAs.
• Collaborate cross-functionally with internal stakeholders and external partners.
• Review and approve SOPs and other Quality documentation.
• Support product complaint handling and ensure suppliers are appropriately approved.
• Oversee licensing activities and mock recall preparedness.

Requirements:

• Bachelor's degree in a scientific or allied health field.
• 5+ years of experience in Quality roles within pharmaceutical or life sciences.
• In-depth understanding of GDP and GMP compliance standards.
• Strong communication, organizational, and problem-solving skills.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Auditing experience and qualifications are a plus.

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