Voyager Therapeutics is a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV gene therapy through innovation and investment in vector engineering and optimization, manufacturing and dosing and delivery techniques. Voyager's pipeline focuses on severe neurological diseases in need of effective new therapies, including Parkinson's disease, a monogenic form of ALS called SOD1, Huntington's disease, Friedreich's ataxia, neurodegenerative diseases related to defective or excess aggregation of tau protein in the brain including Alzheimer's disease and other tauopathies, neurodegenerative diseases related to defective or excess aggregation of alpha-synuclein protein in the brain including Parkinson's disease and other synucleinopathies, and severe, chronic pain. Voyager has strategic collaborations with Sanofi Genzyme, AbbVie and Neurocrine Biosciences. Founded by scientific and clinical leaders in the fields of AAV gene therapy, expressed RNA interference and neuroscience, Voyager Therapeutics is headquartered in Cambridge, Massachusetts.
Position Description (Role & Responsibilities):
The Manager/Sr. Manager Documentation Systems will be responsible for the administration, and management of the Electronic Documentations Management System (EDMS) and Quality Compliance training at Voyager Therapeutics. The Manager/Sr. Manager Documentation Systems will assure the overall compliance of the overall EDMS and training with Voyager's policies and standards. Additional responsibilities include, but are not limited to authoring, reviewing and approving Policies, Standard Operating Procedure, and other related GXP documents in support of the Quality operations. The incumbent will represent Quality in project teams and ensure the communication and understanding of quality requirements and expectations as relates to EDMS and other programs/projects. They will work directly with the Senior Director, Quality Assurance to ensure that company goals and objectives are obtained and that compliance risks are identified, mitigated, and communicated to senior management. Additional responsibilities and activities may include but are not limited supporting research and CMO documentation needs, conduct of internal audits to ensure document completeness, batch document review as well as audit participation and support.
Lead and manage the overall EDMS as deployed at Voyager including:
EDMS System Administrator for Quality
Manage overall Documentation System inclusive of assisting in the processing, review, approval and uploading of compliance documentation.
Conduct all EDMS user training
Support integration of EDMS with other Quality Systems as deployed (Investigations, Corrective and Preventative Actions, Change Control, Electronic Learning Management System, etc.)
Development and implementation of Quality Metrics related to EDMS
Develop, conduct and maintain New Employee Quality Orientation and Quality Refresher Training.
Develop, review, contribute and approve Policies and SOPs in support of the EDMS, Quality Systems Manual and other functional areas.
Support and participate in GMP audits of CMOs, CROs and suppliers as directed.
Conduct internal compliance audits.
Participate in the development of Regulatory Authority inspection strategies.
Represent Quality in cross-functional Program Teams, as assigned.
Effectively communicate progress and issue resolution to the Senior Director, Quality Assurance and key stakeholder(s) of Program Teams.
Additional Responsibilities may include, but are not limited to:
Assist in the review and approval of CMO Master Batch Records (MBRs)
Assist in the review and approval of executed batch records.
Participate with Manufacturing Sciences in investigations of deviations ensuring the development of Corrective Actions and Preventative Actions (CAPA) and approve investigation and deviation reports.
Participate in the preparation, review and audit of Chemistry and Manufacturing Control (CMC) sections.
Qualifications and Experience:
Bachelors' degree in Biological Sciences
Minimum of 15 years Quality Assurance and regulatory compliance experience in biotech/pharmaceutical environment with recent focus on EDMS and work with various quality systems. GCP and GLP experience a plus.
Demonstrated success managing EDMS and developing and leading training activities
Ability to work independently and manage problem resolution.
Demonstrated knowledge and understanding of quality compliance.
Additional Experience Desired:
Knowledge of various dosage forms and/or delivery systems
Experience conducting internal and external audits.
Excellent technical writing and problem-solving skills
Some domestic travel required (approximately 20%).