About Insmed:

Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency.

Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.

About the Role:

Reporting to the Associate Director, QO Americas-Compliance, the Senior Quality Engineer, Quality Assurance will play a key role in making decisions and executing QA and Regulatory Compliance activities for Insmed. In coordination with Associate Director, specific areas of responsibility include: GMP Product Release process, Drug, Device and Combination Product complaint investigations, QA-GMP Metrics (Management Review) monitoring, Annual Product Quality Reports, Supplier Interface, support change controls, among other QA related activities.

• This position reports directly to the Associate Director, QO Americas-Compliance
• This is an individual contributor position.

Additional representative responsibilities will include, but not necessarily be limited to, the following: 

• Create and maintain Standard Operating Procedures relating to quality engineering functions, such as risk management, validation, and design control.
• Support site inspection readiness activities through simulations, front/back room roles, training, etc.
• Write QMS SOPs as required for outlined responsibilities.
• Assist with training and auditing programs, as well as the review of SOPs, investigations, and manufacturing
• Release or reject: Devices, GMP Materials, Drug Product and Combination Product kits.
• Investigate product complaint trends and the activities required to assure the timely implementation and documentation of corrective actions.
• Monitors quality trends, conducts technical and statistical investigations on quality problems, reporting the results and recommendations in a timely manner.
• Develops and conducts training to assure Regulatory compliance.
• Interfaces with critical suppliers on behalf of Insmed.
• Supports product lifecycle continuous improvement changes.
• Conduct audits to assure compliance to Insmed procedures and specifications, as well as to regulatory requirements.
• Partner with colleagues in other departments to increase the overall effectiveness of the Quality Assurance
• Proficient in analyzing data trends using Excel or Minitab software.

About You:

• BS degree in Engineering, Life Science or related discipline and a minimum of 5 years of relevant Quality Assurance experience; or advanced degree and a minimum of 3 years relevant experience required.
• Must be thoroughly knowledgeable on cGMP's, ISO 13485, and familiar with other Regulatory Requirements applicable to a medical device and combination product manufacturing operation.
• Must perform statistical analysis and capable of analyzing data to solve problems.
• Direct experience with complaint and deviation investigations, root cause analysis, Inspection Readiness Programs in pharmaceutical or medical device products.
• Experience reviewing batch records.
• Experience reviewing/executing validation documents.
• Experience managing Change Control documentation.
• Preferred ASQ CQE and CQA Certification

Travel Requirements:

• 15% Domestic/International Travel

• 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.