Quality System Manager

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)
  3. United States
Philadelphia, USA
Posting date: 14 Apr 2021

Proclinical is currently recruiting for a Quality System Manager with a pharmaceutical company located in Philadelphia, PA.

Job Responsibilities:

  • Creation, review, approval, closure and monitoring of deviations, investigations, CAPAs, change controls and associated quality risk assessments in compliance with internal and external requirements.
  • Collaborate with stakeholders to identify and implement value-added improvements to the QMS.
  • Establish new and improve existing forums for performance monitoring and end user support.
  • Proactively identify risks, issues and best practices within the QMS on an ongoing basis
  • On-time completion of assigned projects.
  • Author, review and approve QMS procedural documentation and working practice documents.
  • Create and deliver Quality Systems training
  • Participate in inspection readiness activities and internal/external audits and inspections.

Skills and Requirements:

  • 10 years' + Quality Systems within the pharmaceutical industry.
  • In-depth knowledge of global GCP, GLP, GVP, GMP and GDP requirements for quality systems.
  • Demonstrated critical thinking and problem-solving skills.
  • Direct experience with development and approval of deviations, CAPAs and Change Controls.
  • Prior experience in project leadership within a matrix environment.
  • Prior experience training and coaching for skill development.
  • Direct experience with TrackWise desired.

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.