Quality Systems Manager

POSITION: Quality Systems Manager

The Quality Systems Manager will be responsible for overseeing and ensuring compliance with current Good Practices (GxP) for applicable GxP systems, including document management (EDMS), training (LMS) and the electronic quality management system (eQMS). This role will coordinate and execute document management activities in an effective and compliant manner. This role will also provide training and maintain training compliance of all applicable stakeholders that impact clinical and commercialization activities. Additionally, this role will collaborate with internal and external teams, ensuring alignment of quality standards and the timely execution of all deliverables.

The individual will possess a strong hands-on expertise in GxP quality systems and operations within the biotech industry.

Key Responsibilities

• Documentation Management: Perform document control duties to manage the creation, review, approval, revision, obsoletion, and storage of GxP documents (SOPs, Work Instructions, Policies, etc.) and records. Additionally, this role may require QA review of other records and deliverables. Responsible for the ongoing management of the electronic Document Management System (eDMS).
• Quality Systems Management (eQMS): Experience with systems for processing Deviations, Change Controls, Audits, CAPAs, Investigations, Vendor Management, Complaints, etc. Additionally, evaluate system functionality, evaluate new features from periodic releases and assist with the implementation of value added features.
• GxP Training Management: Oversee the training process to maintain compliant training for GxP stakeholders. Support the establishment of training curricula and training materials. Track completion rate of training of stakeholders. Responsible for the ongoing management of the training system.

• Non-GxP System Support: Serve as the Corporate Training Coordinator and support day-to-day Corporate Document Management and Training activities, including ensuring corporate documents are maintained in the appropriate system and assigned correctly to support broader business needs.

• Reporting and Metrics: Support regulatory inspections and audit requests (FDA, EMA, etc.). Support the implementation, maintenance, and reporting of quality metrics and KPIs to ensure alignment with company objectives. Prepare materials for Quality Management Review meetings, including KPI summaries, quality reports, and trending analyses to support management oversight and continuous improvement.

• GxP Cross-functional Collaboration: Partner with IT, CMC, Supply Chain, Clinical Operations, Clinical QA, Biometrics, Regulatory Affairs, and other GxP teams to implement procedures, training, quality activities, and ensure quality compliance throughout the document and product lifecycle. Assist with the coordination of periodic SOP Committee meetings with various departmental leadership.

Qualifications

• Education:
• Bachelor's degree in Life Sciences, Engineering, or a related field.
• Experience:
• Minimum 3-5 years of experience in quality systems, quality assurance, document management/training management within the biotechnology or pharmaceutical industry.
• Experience with Phase 3 clinical trials and the transition to commercialization is highly preferred.
• Skills & Competencies:
• Expertise in GxP, regulatory requirements, and industry best practices (FDA, EMA, ICH).
• Ability to collaborate with cross-functional teams and complex initiatives.
• Excellent knowledge of quality systems, documentation, and compliance management.
• Exceptional problem-solving, troubleshooting, and analytical skills.
• Strong communication and presentation skills, both written and verbal.
• Ability to work effectively with communication and office tools in a remote, fast-paced, and evolving environment.

The salary range for the Senior Manager Quality Systems is expected to be between $170,000 and $180,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.