Manager - Quality Systems

Cardurion Pharmaceuticals • Burlington, MA

24d • Hybrid

About The Position

The Manager – Quality Systems reports to the Vice President – Head of Quality and executes Cardurion’s Quality Systems requirements for GxP Document Management and the GxP Training Program. The role supports the development, implementation, and maintenance of Quality Systems and assists GxP functions with developing, reviewing, approving, issuing, and maintaining quality policies and procedures. It also provides technical and administrative support to electronic quality management system (eQMS) users and administers training curricula and compliance reporting through the eQMS.

As an internal subject matter expert, the Manager works with the Quality Team and GxP functional groups to support effective execution of company Quality System requirements and compliance with applicable regulations, guidelines, and industry standards. The position also contributes to performance monitoring and continuous improvement of Quality Systems and related processes, policies, and procedures. This role is required to be onsite in the Burlington office three days per week.

Requirements

• Minimum bachelor’s degree in life sciences or a relevant discipline.
• Minimum of 5 years of pharmaceutical quality assurance and GxP regulatory compliance experience supporting GxP document management and GxP training programs.
• Hands-on experience administering electronic document management systems (eDMS), electronic learning management systems (eLMS), and/or electronic quality management systems (eQMS).
• Experience administering Box GxP and ZenQMS software.
• Working knowledge of US and EU GxP requirements for document management, training program administration, data integrity, and pharmaceutical quality systems.
• Strong oral and written communication skills.
• Ability to provide eQMS training and guidance to system users.
• Ability to prepare standard operating procedures, work practices, and user guides related to Document Management and Training Quality System requirements.
• Ability to develop and deliver training presentations and prepare and present Quality System performance management reports to colleagues at all organizational levels.
• Ability to manage multiple projects and competing priorities and collaborate cross-functionally in a dynamic, fast-paced environment.

Responsibilities

• Administer the Cardurion eQMS for Quality Assurance, ensuring it remains validated and compliant with Documentation Management Quality System requirements and procedures.
• Develop and maintain standard operating procedures, work practices, and user guides for eQMS use.
• Develop training materials and train and troubleshoot for eQMS users.
• Assist users with the eQMS lifecycle for Quality Policies and Procedures, including drafting, review, approval, and issuance.
• Identify opportunities to optimize document management processes and procedures.
• Manage eQMS use and implement changes and functionality that improve GxP compliance and user efficiency.
• Collaborate with Information Technology to evaluate and implement eQMS changes and improvements.
• Fulfill GxP documentation requests from internal functions, business partners, and regulatory agencies, as appropriate.
• Support regulatory inspections through document preparation and retrieval.
• Stay current with regulatory and industry requirements and trends for GxP document management, GxP training, and pharmaceutical quality systems.
• Administer the GxP Training Program and ensure compliance with Cardurion’s Training Quality System requirements and procedures.
• Develop and issue training compliance management reports, such as on-time training performance reports.
• Develop and maintain procedures, work practices, and user guides for managing the eQMS training module.
• Train users on the eQMS training module and provide troubleshooting support.
• Collaborate with functional managers to develop role- or department-based training curricula, maintain curricula in the eQMS, and ensure they remain current.
• Track progress of the Cardurion Quality Systems Plan and issue periodic progress reports as directed.
• Follow up with task owners on Quality Systems Plan action items to support timely completion.
• Support functional managers in developing standard operating procedures and work practices as required.

Benefits

• Healthcare coverage including medical, dental, and vision.
• Fully funded Healthcare Savings Account for the high-deductible PPO plan.
• Four weeks of paid time off annually.
• Ten company-paid holidays and year-end shutdown.
• 401(k), with traditional and Roth options and company match.
• Company-paid insurance coverage, including life insurance and short- and long-term disability.
• Flexible spending accounts for medical and dependent care expenses.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager