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