Manager of Quality Systems Engineering
1 week ago
*Hybrid role - 2-3 days - may vary based on business requirements
Position Overview
The Technical Operations division is dedicated to the development of our pharmaceutical products for clinical trials and the subsequent scaling of these products for commercial distribution. Our team of engineers, technicians, scientists, and support personnel are tasked with constructing and upholding the advanced manufacturing processes and facilities of the organization. We ensure quality assurance and quality control to comply with regulatory standards while managing the procurement of essential goods and services to facilitate manufacturing and oversee the global distribution of our products to patients. Join our team to contribute significantly to the well-being of patients.
Role Summary
The Quality Systems Technical Manager plays a pivotal role in guaranteeing that the Quality Systems of the organization, including Documentation, Deviation Management, Corrective and Preventive Actions (CAPA), Change Control, Self-Inspections, and Risk Management, are systematically implemented and adhered to.
Key Responsibilities:
- Engage in preparation for inspections, provide support during regulatory inspections, and participate in self-inspection activities.
- Analyze quality system metrics and trends.
- Collaborate cross-functionally with management both within and outside the Technical Operations to ensure uniform application of quality systems.
- Contribute to initiatives aimed at enhancing quality systems and mapping processes.
- Draft and manage site-specific Quality Technical Agreements.
Qualifications:
A Bachelor’s or Master’s degree, preferably in the life sciences.
Experience:
A minimum of 6 years of experience in the pharmaceutical industry or a related field.
Proven understanding of current Good Manufacturing Practices (cGMPs), Health Authority Regulations, Quality Systems, and technical knowledge of manufacturing processes.
Capability to interpret technical information concerning analytical methods, manufacturing processes, and regulatory requirements.
Familiarity with FDA, European, and international regulatory standards.
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