Turnstone Biologics Inc. is the leading virus-based immuno-oncology biotechnology company developing novel oncolytic vaccine therapeutics for cancer patients. Our first-in-class platform technology attacks tumors using a two-pronged approach: targeted and robust tumor killing using an oncolytic virus, in combination with a cancer vaccine that generates long-lasting anti-tumor immune responses. Turnstone is building a world-class, high-performing team that embraces being a learning organization with a sense of urgency. Turnstone has a seasoned board of directors and venture capital partners, is enrolling clinical studies, has a rich development portfolio, and highly active R&D efforts led by a world-class scientific management team. Turnstone is co-located in Ottawa, Canada and New York, USA. For more information, please visit www.turnstonebio.com.
What would it be like?
Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding are what we call ‘another day at Turnstone’? At Turnstone, the science drives decision making, and our drugs are designed with the patient in mind. Like the disease we’re fighting, our platform is complex, and transformative. If you’re a passionate person, and our science excites you – this opportunity may be for you.
Reporting to the Associate Director of Quality, The Quality Assurance Manager will be responsible for the QA oversight of day-to-day GMP Operations at the Contract Manufacturing Organizations and Contract Labs. Additionally, you will assist in conducting audits of vendors and associated documentation activities.
· Develop, establish and maintain the QA programs, policies, and procedures to ensure GxP compliance of clinical trial material.
· Perform record review, and disposition activities for clinical trial material including conducting the comprehensive Quality assessment.
· Lead investigations with vendors and interdepartmental teams to resolve potential product quality issues.
· Oversee the generation, review and/or disposition of internal and external documents used in GxP activities.
· Act as the single point of QA contact with vendors, contract facilities and joint development collaborators for contracts, validation activities, change management and other QA issues (e.g., Master Virus Bank to Drug Product)
· Drive the implementation of other quality systems, including departmental and corporate procedures, to ensure compliance with GxPs.
· Proven ability to interpret regulatory agency policies and guidance as it pertains to QA issues.
· Serve as the lead in the review of manufacturing, testing and labeling/packaging batch records, and CMC documents submitted to regulatory agencies.
· Responsible for the development of work instructions and/or standard operating procedures.
· Bachelor’s degree in a scientific or engineering discipline. Master’s preferred.
· 7 years of experience in a related industry. Virus and/or biologics experience preferred.
· 2+ years of auditing and batch record review experience.
· Experience with Veeva a plus.
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.