We are looking for a Senior Manager/Manager, Quality Documentation & Training who is passionate about their profession and inspired by being part of team, working in life sciences, to bring a therapy to patients. This is an opportunity to make an impact while being part of a historically significant company that is making a difference to the lives of millions of people.
Responsible for quality document control and employee training in a clinical-stage lentiviral-based gene therapy company. The individual will be responsible for developing, enhancing and maintaining quality documentation and training systems for GxP processes.
- Develop, enhance and maintain the Document Management System in compliance with applicable regulatory requirements. This includes the implementation of an electronic Documentation and Learning Management System.
- Responsible for development, deployment and maintenance of effective and efficient procedures surrounding document control, training and records management.
- Create and manage controlled document life cycle activities including, but not limited to: assignment of document numbers, issuing new documents, document change control, periodic review, storage and inventory of Quality documents and records.
- Responsible for the development, deployment and maintenance of the corporate records management program and records retention schedule.
- Develop training curricula for employee functions for GCP/GLP/GMP and GVP processes.
- Conduct and/or facilitate instructor led training programs. Work with functional areas to ensure employees receive and document job-specific training, as required.
- Effectively monitor training compliance within AVROBIO.
- Establish and deploy metrics for documentation and training management leading to action plans for continuous improvement.
- Maintain the quality documentation system in a state of inspection readiness. Provide support during internal and external audits and inspections.
- Additional responsibilities will be assigned by the Senior Director, Quality Assurance.
Minimum Requirement / Qualifications:
- BA or BS degree required.
- Minimum 5-7 years of experience in pharmaceutical / biopharmaceutical industry document control. Experience building a system from ground up is a plus.
- Knowledge of GxP and QA principles, practices and standards.
- Excellent verbal and written communication skills to effectively communicate with site staff.
- Strong organizational skills, attention to detail, and knowledge/experience with electronic data management/learning management systems.
- Experience implementing and administering Veeva Quality Docs a plus
- Ability to prioritize and handle multiple tasks at once while working independently and communicating regularly with Senior Director of Quality.
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AVROBIO, Inc is an EEO employer
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.