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Technical Quality Manager
1 month ago
We are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
A high-level of initiative, energy, and motivation are key role requirements, as well as organizational skills and the ability to motivate others.
The Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain the company's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Join our team and make a meaningful impact on patients' lives.
Summary Description
The Quality Systems Technical Manager is responsible for ensuring Quality Systems, such as Documentation, Deviation, CAPA, Change Control, Self-Inspection and Risk Management are consistently administered and followed.
Responsibilities:
- Participate in inspection readiness, regulatory inspection support and self- inspection activities.
- Quality system metrics and trending.
- Works cross functionally with management within and outside Technical Operations to ensure consistency of use of the quality systems.
- Participate in quality system improvement and process mapping initiatives.
- Author and own site Quality Technical Agreements.
Education:
- BS/MS preferably in the life sciences
Certifications & Licenses
- CAPA
Skills Required
- QUALITY SYSTEMS MANAGEMENT
- CGMPS
Additional Skills
- CHANGE CONTROL
- COMPLIANCE/REGULATORY
- INTERNAL QUALITY AUDITS
- OPERATIONS
- RISK MANAGEMENT
Experience:
- 6+ years experience in pharmaceutical or related industry.
- Demonstrated knowledge of cGMPs, Health Authority Regulations, Quality Systems and technical expertise in manufacturing processes.
- Ability to comprehend technical information related to analytical methods, manufacturing processes and regulatory expectations.
- Familiarity with FDA, European and international regulatory requirements.