Manager - Quality Systems
About The Position
Cardurion Pharma is a clinical-stage biotechnology company focused on discovering and developing novel therapeutic approaches for cardiovascular disease. The Manager – Quality Systems role is responsible for executing the requirements of the Cardurion Quality Systems for GxP Document Management and the GxP Training Program. This position provides support to various GxP functions, facilitating the development, review, approval, issuance, and maintenance of Quality System Policies and Procedures. It also offers technical and administrative support for electronic quality management system (eQMS) users and manages the GxP Training Program through the eQMS, including training curricula and compliance reporting. The incumbent acts as an internal subject matter expert, working with the Quality Team and GxP functional groups to ensure effective execution of Quality System requirements and compliance with GxP regulations. The role also contributes to the development, performance monitoring, and continuous improvement of the company’s Quality Systems.
Requirements
- Minimum BS degree in the life sciences or a relevant discipline.
- Minimum of 5 years pharmaceutical quality assurance and GxP regulatory compliance experience in support of GxP document management and GxP training programs.
- Hands-on experience in administration of electronic document management systems (eDMS), electronic learning management systems (eLMS), and/or electronic quality management systems (eQMS).
- Experience with administration of Box GxP and ZenQMS software required.
- Working knowledge in the application of US and EU GxP requirements related to document management, training program administration, data integrity, and pharmaceutical quality systems.
- Strong oral and written communication skills.
- Ability to effectively provide eQMS training and guidance to system users.
- Ability to prepare standard operating procedures, work practices, and user guides related to the administration of Document Management and Training Quality System requirements.
- Oral and presentation skills to address colleagues at all levels of the organization.
- Ability to work on multiple projects, manage competing priorities, and collaborate cross-functionally in a dynamic fast-paced environment.
Responsibilities
- Overall responsibility for Quality Assurance administration of the Cardurion eQMS, including ensuring it is maintained in a validated state and in compliance with documentation management requirements.
- Develops and maintains standard operating procedures, work practices, and user guides related to eQMS use, and develops training materials and provides support to eQMS users.
- Assists users in the document lifecycle (drafting, review, approval, issuance) for Quality Policies and Procedures using the eQMS.
- Optimizes and improves document management processes and procedures, and manages eQMS use to implement changes that enhance GxP compliance and user efficiency.
- Collaborates with Information Technology to evaluate and implement eQMS changes and improvements.
- Fulfills GxP documentation requests from internal groups, business partners, and regulatory agencies, and supports regulatory inspections.
- Remains current in regulatory and industry requirements for GxP document management, GxP training, and pharmaceutical quality systems.
- Responsible for Quality Assurance administration of the GxP Training Program, ensuring compliance with training system requirements and procedures.
- Develops and issues management reports for training compliance.
- Develops and maintains standard operating procedures, work practices, and user guides for the eQMS module for GxP training.
- Develops training materials and provides training and troubleshooting support to users of the eQMS training module.
- Collaborates with functional managers to develop role or department-specific training curricula and maintains these curricula in the eQMS.
- Optimizes and improves GxP training processes and procedures, and manages eQMS use to implement changes that enhance GxP compliance and user efficiency.
- Supports Quality Systems development and implementation, including tracking progress of the Quality Systems Plan (QSP) and issuing progress reports.
- Conducts follow-up on QSP Action Items with task owners to ensure timely completion.
- Provides support to functional managers in the development of standard operating procedures and work practices.
Benefits
- Healthcare coverage including medical, dental and vision
- Fully funded Healthcare Savings Account for high-deductible PPO Plan
- 4 weeks paid time off annually
- 10 company paid holidays and year-end shut down
- 401k (traditional and Roth offered) with company match
- Cardurion-paid insurance coverage, including life insurance, short-term and long-term disability
- Flexible spending accounts for medical and dependent care expenses
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What This Job Offers
Job Type
Full-time
Career Level
Manager
