Quality System Manager

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.

#LI-BC1