Insmed is a biopharmaceutical company dedicated to improving the lives of patients battling serious lung diseases. We are focused on the development and commercialization of novel, targeted inhaled therapies for patients with high unmet needs battling orphan lung diseases. Insmed is a sustainable, patient-centered biopharmaceutical company at the intersection of Pulmonary, Orphan and Infectious Diseases.
Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.
Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.
This position will have responsibility for the quality assurance oversight of manufacturing operations at Insmed’s CMO including the review of batch records and product release, oversight of deviations and CAPAs, and ensuring good communication of issues, developments and plans at the CMO with Insmed Quality Assurance.Also, serve as a conduit from the global Quality Assurance organization back to CMO Quality Assurance.
• On-site responsibility for the QA oversight of manufacturing operations at Insmed’s CMO. This includes real-time oversight of CMOs execution of commercial batch manufacturing, including, but not limited to: technical review of quality documentation, Insmed’s release of production batches, and oversight/management of any process improvement related projects.
• Auditing of facilities.
• Bachelor’s degree (advanced degree is preferred) with a minimum of 7 years of experience in a Quality Assurance function with a good understanding pharmaceutical manufacturing processes (preferably of products marketed in the US, EU and Japan) required.
• Experience leading teams tasked with implementation of process improvements within a regulated environment.
• Experience with commercial CMO operations.
• Experience in the design and operation of pharmaceutical aseptic processing equipment.
• Working knowledge of quality systems, validation principles, engineering design, and statistical process control fundamentals.
• Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment.
• Strong verbal and written communication skills are essential.
• Ability to work independently, remote from central leadership is required.
• High energy, innovative “can do” attitude is required.
• Lives in or willing to relocate to Toronto/Mississauga area.