Manager - Quality Systems

The Role:
Reporting to the Vice President - Head of Quality, the Manager - Quality Systems is responsible for executing the requirements of the Cardurion Quality Systems for GxP Document Management and the GxP Training Program, as well as for providing general support for the development, implementation, and maintenance of the required Cardurion Quality Systems.

The position provides support to the various GxP functions within Cardurion in facilitating the development, review, approval, issuance, and maintenance of Quality System Policies and Procedures and provides technical and administrative support for electronic quality management system (eQMS) users. The position also has responsibility for the administration of the GxP Training Program through the eQMS, including the management of training curricula and reporting on training compliance.

As the internal subject matter expert, the incumbent works directly with the Cardurion Quality Team and members of the various GxP functional groups to ensure effective execution of the Cardurion Quality System requirements and compliance with the applicable GxP regulations, guidelines, and industry standards regarding GxP Document Management and GxP Training.

In addition, the position contributes to the development, performance monitoring, and continuous improvement initiatives related to the company's Quality Systems and their associated processes, policies, and procedures.

This role is required to be onsite in Burlington office 3 days a week.

Here's What You'll Do:

Overall responsibility for Quality Assurance administration of the Cardurion eQMS, including:

• Ensuring the eQMS is maintained in a validated state and in compliance with the Cardurion Documentation Management Quality System requirements and procedures.
• Develops and maintains standard operating procedures, work practices, and user guides related to the use of the eQMS. Develops training materials and provides training and troubleshooting support to eQMS users as required to ensure proper use of the system.
• As needed, assists users in facilitation of the document lifecycle (drafting, review, approval, issuance) for Cardurion Quality Policies and Procedures using the eQMS.
• Continually explores opportunities to optimize and improve the document management processes and procedures. Actively manages use of the eQMS to identify and implement changes and functionality that enhances GxP compliance and user efficiency.
• Collaborates with Information Technology to evaluate and implement eQMS changes and improvements.
• Fulfills GxP documentation requests from internal functional groups, business partners, and regulatory agencies, as appropriate. Supports regulatory inspections through document preparation and retrieval, as required.
• Remains current in the regulatory and industry requirements and trends for GxP document management, GxP training, and pharmaceutical quality systems.

Responsible for Quality Assurance administration of the GxP Training Program, including:

• Ensuring the GxP Training Program is maintained in compliance with the Cardurion Training Quality System requirements and procedures. Develops and issues management reports for training compliance, e.g., on-time training performance.
• Developing and maintaining standard operating procedures, work practices, and user guides related to the management of the eQMS module for GxP training.
• Developing training materials and providing training to users as required to ensure proper use of the eQMS system training module. Also provides user troubleshooting support as needed.
• Collaborating with functional managers to develop training curricula by role or department, as applicable. Maintains training curricula in the eQMS and ensures curricula are current.
• Continually explores opportunities to optimize and improve the GxP training processes and procedures. Actively manages use of the eQMS to identify and implement changes and functionality that enhances GxP compliance and user efficiency.

Supports Quality Systems development and implementation, including:

• Tracking progress of the Cardurion Quality Systems Plan (QSP) and issuing periodic progress reports, as directed.
• Conducting follow up on (QSP) Action Items with the various task owners to ensure timely completion of assigned tasks.
• Providing support to functional managers in the development of standard operating procedures and work practices, as required.

Here's What We'll Bring to the Table:

• Highly competitive package with 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
• A suite of Cardurion-paid insurance coverage, including life insurance, short-term and long-term disability
• Flexible spending accounts for medical and dependent care expenses

Expected Pay Range: $135,000 - $142,000

Requirements

Here's What You'll Bring to the Table:

• 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 the US and EU GxP requirements as 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, e.g., development and delivery of training presentations and development and presentation of management reports on Quality System performance.
• Ability to work on multiple projects, manage competing priorities, and collaborate cross-functionally in a dynamic fast-paced environment.