The Senior Manager, Quality Compliance is responsible for providing compliance guidance and support for clinical-stage lentiviral-based gene therapies. The individual will be responsible for ensuring quality systems (including internal/external audits, vendor management, deviations / CAPA management, and change management) while driving compliance with applicable guidelines and regulations.
- Responsible for compliance with applicable corporate policies and procedures.
- Responsible for the development and implementation of Global SOPs/Standards/Guidelines with respect to Quality Systems Management and ensure alignment with AVRO Quality philosophy, phase of development, and industry best practices.
- Create tools and plans to maintain an Approved Vendor List.
- Interprets relevant regulations and guidelines to assist teams with inspections, audit responses, and investigations, as required.
- Create strong partnerships with external GxP contract organizations to ensure compliance with applicable guidelines and regulations.
- Performance and/or oversight of vendor compliance audits. Identify top compliance risks and communicate to AVROBIO management.
- Assist in performance of internal audits, including audit plans and reports. Review and evaluate internal audit responses with current industry expectations to assure compliance.
- Ensure timely completion of deviations, CAPAs and change controls. Follow-up to ensure implementation, compliance and continued efficacy.
- This role is responsible for continual monitoring of key quality indicators, including trend analysis.
- Independently takes initiative to resolve problems and mitigate risk. Escalates significant issues to management.
- Maintains audit files and databases to ensure vendor documentation is current and complete.
- Assist in the development of compliance and quality training, as required.
- Additional responsibilities will be assigned by the Senior Director, Quality Assurance.
- Bachelor’s degree in a scientific or health-related field is required.
- Minimum of 10 years of experience in pharmaceutical industry, with ~ 5 years in a Quality/Compliance role.
- Considered a subject matter expert and competent in the application of GxP and QA principles, practices and regulations. (FDA, ICH, Global).
- Ability to build relationships with internal stakeholders and external vendor/partners, and influence across disciplines and all levels.
- Highly motivated, flexible and have excellent organizational and communication skills.
- Ability to prioritize and handle multiple tasks at once while working independently and communicating regularly with Senior Director of Quality.
- Gene therapy and/or GCP experience a plus.
- Ability to travel (up to 30% domestic and international).
To apply, email your resume to: firstname.lastname@example.org
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.