Quality Assurance Manager (Operations)

The Quality Assurance Manager (Operations) as part of the Operations team will be tasked with supporting the clinical manufacturing activities at Oncorus’ cGMP manufacturing facility located in Andover, MA. This is a unique opportunity to join a rapidly growing Quality Assurance function as one of the key individuals that will be tasked with expanding the operations team and supporting manufacturing activities to ensure the highest quality standards are maintained. As the Quality Assurance Manager (Operations), this individual will be challenged with establishing quality initiatives in support of a new facility start-up ranging from initial system implementation through process transfer to manufacturing. This individual will be the key counterpart to the Manufacturing manager, working closely together to ensure the success of our manufacturing processes under the highest level of quality.

This position is an onsite role. 

• Act as the key counterpart to the manufacturing manager, working together to ensure success of the manufacture of products.
• Represent the quality assurance group as a member of CMC project teams.
• Build a quality operations team focused on supporting cGMP manufacturing activities including on-the-floor support, visual inspections, and making real time decisions related to operations.
• Support the organization in maintaining inspection readiness by performing routine site walkthroughs of the manufacturing suites, partnering with the manufacturing team on suite maintenance, Quality best practice implementation and troubleshooting when issues arise.
• Author, review, and approve GMP documentation (SOPs, master batch records, executed batch records, testing records, protocols and associated summary reports, test methods, specifications, deviations, change controls, corrective/preventive actions, out-of-specification/atypical investigations, etc. to ensure GMP compliance, that all steps have been executed correctly, and that all limits and specifications have been met).
• Perform batch disposition of incoming raw materials, consumables, Cell Banks, Plasmid, Drug Substance, and Drug Product (including labeled and packaged materials).
• Work collaboratively with cross functional teams, partners, and vendors to gather background knowledge needed to complete assignments.
• Independently handle complex investigations in cross-functional areas.
• Assist with internal and external audits as required.
• Provide QA oversight for cGMP activities outsourced to contract organizations.
• Practice safe work habits and adhere to Oncorus’ safety procedures and guidelines.
• Other duties as assigned by management.

• Bachelor’s degree in biology, chemistry, or other life science and greater than 8 years of relevant industry experience in Quality Assurance in a Pharmaceutical/Biotech cGMP regulated environment or Master’s degree in biology, chemistry or other life science with greater than 6 years of relevant industry experience in Quality Assurance experience in a Pharmaceutical/Biotech cGMP regulated environment.
• Experience supporting Quality Operations required. Experience with both early and late phase clinical manufacturing preferred.
• A working knowledge of cGMP requirements for the manufacture of clinical phase material in both the US and EU, including sterile manufacturing, strongly preferred.
• Experience with cell, protein, RNA, and/or viral products preferred.
• Experience with cell culture, single-use technologies, and aseptic processing preferred.
• Understanding of regulatory guidance on cell and gene therapy products is a plus.
• Expertise working in compliance with cGMP regulations and generating/approving cGMP documentation.
• Excellent verbal and written communication skills. Strong communicator and collaborator who possesses a flexible approach to problem solving and ability to apply risk-based decision making.
• Experience with cGMP in a working manufacturing environment strongly preferred.
• Investigational skills including Root Cause Analysis and Product Impact Assessments.
• Ability to manage multiple projects with minimal oversight in an evolving environment.
• Previous management experience a plus.
• Previous experience gowning preferred.