Quality Systems Assurance Lead
2 weeks ago
Quality Systems Assurance Manager
Location: Remote/Hybrid
Contract Duration: 12 Months
Employment Type: No Corp-to-Corp
This position offers a hybrid work model, requiring in-office presence 2-3 days a week, with flexibility based on business requirements.
Company Overview
TalentBurst, an Inc 5000 company, is a leader in providing innovative solutions for patients suffering from rare genetic disorders. Our mission is to develop therapies that address unmet medical needs, particularly for conditions that are challenging to diagnose and treat.
Role Overview
The Quality Systems Assurance Manager will oversee the effective implementation and management of the company’s Quality Systems, which include Documentation Control, Deviation Management, Corrective and Preventive Actions (CAPA), Change Control, Self-Inspection, and Risk Management.
Key Responsibilities:
- Support inspection readiness and assist during regulatory inspections and self-assessment activities.
- Analyze quality system metrics and identify trends for continuous improvement.
- Collaborate with cross-functional teams to ensure uniform application of quality systems across the organization.
- Engage in initiatives aimed at enhancing quality systems and mapping processes.
- Draft and maintain site-specific Quality Technical Agreements.
Qualifications:
Education: Bachelor’s or Master’s degree in Life Sciences or a related field.
Experience:
- A minimum of 6 years of experience in the pharmaceutical industry or a closely related field.
- Proven expertise in current Good Manufacturing Practices (cGMP), regulatory requirements, and quality systems.
- Strong ability to interpret technical documentation related to analytical methods and manufacturing processes.
- Familiarity with FDA, European, and international regulatory standards.
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