Quality Assurance Technical Manager
2 weeks ago
Company Overview: Harvest Technical Services, Inc. is a pioneering organization dedicated to providing innovative therapeutics for patients facing serious and life-threatening rare genetic disorders. Our focus is on conditions that currently lack effective treatment options, particularly those affecting children.
Role Summary: The Quality Assurance Technical Manager plays a crucial role in overseeing the company's Quality Systems, including Documentation, Deviation Management, Corrective and Preventive Actions (CAPA), Change Control, Self-Inspection, and Risk Management. This position ensures that these systems are consistently implemented and adhered to across the organization.
Key Responsibilities:
- Support inspection readiness and provide assistance during regulatory inspections and self-inspection activities.
- Analyze quality system metrics and trends to identify areas for improvement.
- Collaborate cross-functionally with management within and outside of Technical Operations to ensure uniform application of quality systems.
- Engage in initiatives aimed at enhancing quality systems and process mapping.
- Draft and manage site-specific Quality Technical Agreements.
Qualifications:
- Educational Background: BS/MS degree, preferably in life sciences.
Experience Required:
- A minimum of 6 years of experience in the pharmaceutical industry or a related field.
- Proven expertise in current Good Manufacturing Practices (cGMPs), regulatory requirements, and quality systems.
- Strong ability to interpret technical information related to analytical methods, manufacturing processes, and regulatory expectations.
- Familiarity with FDA, European, and international regulatory standards.
The compensation for this position is competitive and will be determined based on internal equity, geographic location, and the candidate's relevant skills and experience.
Harvest Technical Services is committed to fostering a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other protected class.
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Quality Assurance Technical Manager
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