Quality Systems Manager - (Pharma/Biotech/Medical Device) - Exton, PA - HYBRID role!!

No H1B and/or C2C please!!

One of our leading Pharmaceutical client is looking for a Quality Systems Manager (Pharma/Biotech/Medical Device), responsible for maintaining and improving Quality Systems for the client’s site to ensure on-going compliance to applicable compendia, GMP’s, and Regulatory guidance. The Quality Systems include quality risk management, documentation, global and local auditing, health authority inspection management, training, event management (deviations, complaints, CAPA), and change control (global and local). Will act as subject matter expert (SME) for GMP and Data Integrity (DI) requirements

Job Title: Quality Systems Manager (Pharma/Biotech/Medical Device)

W2 Contract & HYBRID role

Exton, PA

Required Experience:-

• 5 – 7 years of experience working with Quality Systems (Deviation, Change Control, CAPA, audit, etc.)
• Demonstrated proficiency and experience in working with Quality Systems IT applications
• Training within a regulated Pharmaceutical/biotech/medical device environment
• Understanding and application of CGMP’s (EU, JP, US)
• Detailed knowledge and application with electronic Quality Systems (i.e. TrackWise, Documentum)

Responsibilities:-

• Collaborate and provide expert reviews to ensure records, documents, and Quality Systems meet GMP and DI requirements (promote quality, DI, and GMP awareness).
• Support external and internal audits for the client’s sites.
• Contribute to the oversight of Quality Systems core responsibilities (track, report, adjust) by trending quality metrics for client’s sites.
• Develop and manage processes that ensure the Exton site remains in compliance with global quality polices, regulatory requirements, and industry requirements, including periodic review and consolidation..

If you are a right fit as per the skills requirements and this job excites you then please apply quick!!