Senior Clinical Quality Assurance Specialist/Manager 8/11/2016
JOB DESCRIPTIONAPPLY 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 is based at our new Bridgewater, NJ headquarters facility.
Conducts audits for vendors (including CROs, Central Laboratories, and Investigator Sites), and maintains vendor oversight recommendations. Able to support QA GCP, Medical and Regulatory Compliance. Assists in evaluating compliance of GCP and helps assure all systems, processes and their outcomes comply with applicable international/ national standards, regulations, and guidelines. Understands and has participated in Regulatory Inspections or activities to support Inspection readiness.
Conduct Investigator, Vendor and Internal Audits
Must have significant knowledge base in regulatory requirements by ensuring compliance to ICH E-6 Guideline for Good Clinical Practice in clinical, medical and regulatory activities.
Aid in the identifying risks and mitigation techniques that support Good Clinical Practice.
Utilize a quality approach, to ensure all GCP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellence.
Support the quality assurance program; including assisting with training and auditing programs, review of SOPs, investigations, monitoring reports, and setting quality goals for clinical documents and processes
Aid in the conduct of clinical document audits in support of clinical studies and regulatory submissions.
Support external/internal audit activities, including review of monitoring reports, Essential Documents and other supportive documentation required by regulatory agencies, or customers, to support the quality assurance function. Support other staff members as an additional auditing resource, as needed for clinical site audits, internal audits, vendor audits, and CRO audits.
Support inspections by regulatory agencies by assisting in the organization of and preparation for, coordination, hosting, conduct, documentation and follow-up of regulatory inspections.