Insmed Incorporated-posted about 1 year ago
$139,000 - $195,200/Yr
Full-time • Senior
Bridgewater Township, NJ
Professional, Scientific, and Technical Services

The Associate Director, Pipeline QA & Investigations at Insmed is responsible for overseeing all quality-related activities and processes for pipeline products in clinical phase studies. This role involves managing supplier relationships, conducting audits, batch review and release, and ensuring compliance with quality management systems. The position also facilitates the transition from drug development to commercial product, ensuring that all operations meet regulatory standards and operational excellence.

  • Lead investigations, CAPAs, deviations, and quality events to resolution and closure.
  • Establish and maintain a risk-based and scientific-based quality system and decision-making process.
  • Audit manufacturing facilities of vendors, customers, and outside contract organizations.
  • Facilitate and approve Quality Technical Agreements with vendors.
  • Ensure phase-appropriate GMP operations are compliant while maintaining efficient workflows.
  • Transition phase 3 clinical stage material to commercial success.
  • Manage quality aspects of large scope phase 3 clinical projects from raw materials to manufacturing, packaging, distribution, and release.
  • Prepare, review, and approve external and internal reports and documentation required by regulatory agencies.
  • Act as the company's representative during regulatory agency and customer inspections.
  • Identify and lead operational excellence initiatives within the department and company-wide.
  • Minimum BS degree in Chemistry, Life Science, or related discipline plus 10 years of experience, or a Masters, PhD, or MBA with 7 years of experience preferred.
  • Full understanding of cGMPs, GLPs, and a working knowledge of GCPs.
  • Experience managing FDA inspections and working with regulators and customer audits.
  • Understanding of device regulations and development processes.
  • Familiarity with pharmaceutical product manufacturing processes.
  • Experience with Phase I through IV, particularly Phase III; experience with Regulatory approval, NDAs, and MAAs.
  • Experience in writing manufacturing and lab investigations.
  • Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals.
  • Experience in effectively managing FDA inspections and customer audits.
  • Demonstrated ability to manage staff and projects.
  • Flexible approach to work location and hours.
  • Competitive compensation package including bonus.
  • Stock options and RSU awards.
  • Employee Stock Purchase Plan (ESPP).
  • Flexible Vacation Policy.
  • Generous paid holiday schedule and winter break.
  • 401(k) plan with company match.
  • Medical, dental, and vision plans.
  • Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance.
  • Company-provided short and long-term disability benefits.
  • Unique offerings of pet, legal, and supplemental life insurance.
  • Flexible spending accounts for medical and dependent care.
  • Employee Assistance Program (EAP).
  • Mental Health online digital resource.
  • Well-being reimbursement.
  • Paid leave benefits for new parents.
  • Paid time off to volunteer.
  • On-site, no-cost fitness center at U.S. headquarters.
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