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Manager, Quality Management Systems
2 weeks ago
**Role Summary**:
The QMS Manager is responsible for overseeing the Quality Management System (QMS) processes and systems within OmniaBio. This role ensures that all quality management processes, procedures, and documentation comply with regulatory standards and industry best practices.
The QMS Manager takes a holistic, system-level approach to management the QMS, focusing on its overall structure, performance, and continuous improvement. This individual evaluates and integrates various inputs, such as records, key performance indicators (KPIs), and compliance data, to assess the effectiveness and efficiency of the system. They work to ensure that all components of the QMS are aligned, functioning optimally and compliant with relevant standards and regulations.
In addition, the Quality Systems Manager plays a crucial role in maintaining close communication with business leaders, departments, and various stakeholders. By regularly engaging with these counterparts, they keep a pulse on day-to-day operations, challenges, and emerging needs, allowing them to identify areas for improvement, address inefficiencies, and proactively respond to system gaps or performance issues. This role requires a strategic thinker who can collaborate cross-functionally to drive impactful changes that enhance the overall quality system.
**Responsibilities**:
- ** Implement and Maintain QMS**: Develop and maintain the QMS framework, ensuring alignment with regulatory requirements (e.g., Health Canada, FDA, EMA, ICH Q10). Manage the electronic QMS (eQMS) to ensure accurate and efficient documentation, data integrity, and compliance.
- ** Performance Monitoring**: Ensure timely completion of quality records. Develop and monitor key quality metrics, running the periodic quality metrics review, and providing regular reports to management on the status and performance of the QMS.
- ** Document Control**: Manage document control processes, ensuring all SOPs, protocols, and batch records are properly maintained and accessible.
- ** Training and Development**: Oversee training programs to ensure staff competency and adherence to quality standards.
- ** Corrective and Preventive Actions (CAPA)**: Implement CAPA processes to address non-conformances, prevent recurrence and drive continuous improvement.
- ** Change Control**: Manage the change control process to ensure that all changes to processes, equipment, and systems are evaluated and implemented in a controlled manner.
- **Audit Management**: Support internal and external audits, ensuring timely resolution of audit findings and continuous improvement.
- **Risk Management**: Identify, assess, and mitigate quality-related risks through comprehensive risk management strategies. Develop, implement and maintain risk management tool.
- ** Customer Complaints and Recall Management**: Oversee the handling of customer complaints and coordinate recall activities to ensure timely resolution and compliance with regulatory requirements.
- ** Regulatory Compliance**: Ensure compliance with all relevant regulatory requirements and prepare for audits.
- ** Continuous Improvement**: Drive continuous improvement initiatives to enhance quality processes and outcomes.
- ** Collaboration**: Provide site support and guidance throughout the quality record life cycle. Work closely with other departments to ensure quality objectives are met and integrated into overall business operations.
**Qualifications**:
- Bachelor of Science Degree, specializing in biological or pharmaceutical sciences
- 8-10 years of experience in a Quality role (e.g., Quality Assurance, Quality System Management) within cell and gene therapy, biologics, and/or pharmaceutical manufacturing.
- 3-5 years of direct management experience, with proven success in leading and managing teams.
- Strong technical writing and communication skills.
- Strong knowledge of GxPs (local and global).
- Proven ability to manage multiple projects and priorities effectively.
- Proficiency in electronic quality management systems (eQMS) and related software.
- Quality Systems certification training from a recognized institution is an asset.
**Desired Characteristics**:
- This role requires a strong understanding of applicable GxPs related to quality assurance in the manufacturing, packaging, storage, testing, and distribution of cell and gene products, as well as current industry standards. This knowledge is essential for ensuring the appropriate development and implementation of QMS processes and records, as well as for process improvement.
- This role requires a high level of organization at both the individual and team levels. These abilities are essential for ensuring effective quality system management.
- The QMS Manager must excel in collaborating with a diverse group of personnel and Subject Matter Experts from all internal GxP-related departments and other quality functions.
- Excellent verbal and written communication, along with technical wr
