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Oncorus Senior Manager -Associate Director, Quality Assurance Compliance in Cambridge, Massachusetts

Senior Manager -Associate Director, Quality Assurance

About Oncorus:

Oncorus, Inc. (Cambridge, MA) is an early-stage biotechnology company developing a next-generation oncolytic virus immunotherapy platform to treat cancer. We are seeking a highly motivated, skilled, and enthusiastic candidate to lead our Quality Compliance function. The Sr. Manager/Associate Director of QA Compliance provides compliance oversight at Oncorus and contract manufacturing, testing, research, and/or laboratory organizations.

The ideal candidate will be responsible for:

  • Oversight of Oncorus Quality Compliance, GxP auditing and training program; ensures compliance with current Good Manufacturing Practices (GMPs) and Good Clinical Practices (GCP) and Good Laboratory Practices (GLPs).

  • Oversight for the vendors qualification program; review, evaluation, and approval of contract manufacturing, testing, research, and/or laboratory facilities; and manage all quality agreements.

  • Leads compliance audits as required.

  • Interfaces with vendors and contract manufacturers to address documentation and compliance issue; ensure all audits are followed-up and corrective actions are completed, implemented, and verified.

  • Develop metric reports for management of all issues related to the outcome of the audits.

  • Serve as the primary contact in QA for the oversight of Clinical Studies in US and CAN to ensure compliance with all GCP's from manufacturing, labeling, distribution, and site qualification.

  • Assist in the creation/revision of appropriate SOPs/ training modules.

  • Promote/advance quality awareness; ensure documents and records are kept in compliance with regulations and SOPs.

  • Collaborate with other departments involved in GxP activities to ensure they are commensurate with current GxPs, best practices and corporate objectives.

Previous Experience:

  • B.S. degree in scientific discipline or closely related field is required.

  • At least 10+ years of post-degree Quality experience in the biotechnology/pharmaceutical industry

  • Extensive knowledge of GxP and QA principles, practices, and standards

  • Strong knowledge of global regulations (EU, US)

  • Excellent verbal and written communication skills

  • Ability to prioritize and balance work from multiple projects in parallel.

  • Ability to work independently and as part of a cross-functional team.

  • Ability to adapt to frequent change and thrive in a dynamic and entrepreneurial early-stage environment.