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.
• Minimum BS degree in Chemistry, Life Science or related discipline or an equivalent of ten (10) years of experience in supporting clinical operations.
• Solid understanding of ICH/FDA GCP guidelines essential
• Ability to extrapolate from previous experience to identify issues before they become systemic
• Understand clinical development processes, and FDA inspection procedures.
• Experience with Phase I thru IV, particularly Phase III; experience with Regulatory approval, NDAs and MAAs on a global level.
• Preferably two (2) years of clinical quality experience including performing audits and/or inspection readiness
• Exposure to FDA regulated activities.also required
• Experience developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs.
• Ability to participate in the conduct of internal audits.
• Ability to work independently with variable workloads.
• Ability to multi-task and respond to changing priorities while continuing to move lower priority items forward
.• Up to 30%domestic and/or international travel required
Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.