Insmed Incorporated

Manager, Clinical Quality Assurance

ID
2020-1275
Job Function
Quality Assurance

Company Description

About Insmed!

 

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.

Overview

About the Role!

 

This position is primarily involved in supporting GCP/GLP/GVP compliance by overseeing and assisting with development and maintenance of SOPs, training programs, inspection readiness support, Deviation/CAPA management, and metrics reporting.

Responsibilities

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

 

  • Develop and review SOPs
  • Develop and coordinate GCP/GLP/GVP Training
  • Support regulatory inspection readiness activities
  • Support the management of regulatory inspections
  • Oversee and manage the GCP/GLP/GVP Deviation and CAPA management process using Veeva
  • Develop and periodically report Quality Metrics/KQIs
  • Develop process for collection of regulatory intelligence information (i.e. regulations, guidance documents, etc.)
  • Communicate relevant regulatory intelligence information to relevant internal stakeholders
  • Perform and support internal audits
  • Prepare, review and approve internal and external reports and other documentation required by regulatory agencies, or customers, to support the quality assurance function
  • Contribute to operational excellence initiatives, both in the department and companywide, which result overall process improvement in both areas
  • Partner with colleagues in Clinical, Regulatory, and Medical departments to increase the overall effectiveness of the Quality role, and instill a Quality Improvement approach in all activities

Qualifications

About you!

  • Minimum Bachelor’s degree in Chemistry or related life sciences is required
  • A minimum of 5 years' experience supporting GCP or GLP or GVP functions
  • Full understanding of ICH/FDA GCP guidelines
  • Understanding of good documentation practices, ability to organize and utilize electronic systems to track and manage information
  • Knowledge of clinical development process and Phase I-IV trial operations and the related regulations/guidelines
  • Experience with Phase I thru IV, particularly Phase III; experience with Regulatory approval, NDAs and MAAs
  • Experience with effectively managing regulatory inspections, working with regulators and customer audits
  • Experience developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs
  • Experience with Veeva is desired
  • Must have excellent communication skills (verbal and written)
  • Highly organized with strong attention to detail, clarity, accuracy and conciseness
  • Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)

Travel Requirements: 

Up to 15% travel, both domestic and/or international

Additional Information

We offer a competitive benefits package that includes healthdentalvisionwellness programs, employee discount programs, 401k and more. This position is also bonus eligible.

 

Insmed is an Equal Opportunity Employer and will evaluate 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.

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