Current Job Openings
PTS Advance is looking to speak with Quality Leaders to join our global pharmaceutical client in the greater Boston area. In this position, you will focus on enhancing compliance and ensuring the site is always inspection ready. This is a hybrid position that offers a flexible working environment and is a long-term contract.
Main Responsibilities
- Support compliance initiatives
- Responsible for CAPA and change management
- Development of leading metrics and advancement of reporting for operational review
- Buildout process for site risk management - to include gap assessment evaluation from inspections
- Proactively monitor site compliance metrics to ensure meeting/ exceeding expectations
- Participate in continuous improvement initiatives, including projects resulting from value stream mapping activities
- Real-time Inspection Readiness
- Provide feedback to site Inspection Readiness Plans associated with regulatory filings
- Participate in and follow up on activities from compliance walkthroughs
Required Qualifications
- Bachelor's degree in a scientific or allied health field and 8+ years of relevant work experience, or Master's degree with 5+ years relevant experience, or relevant comparable background
- Candidate must have experience in a Quality Assurance role supporting or relevant experience
- Demonstrated success independently leading cross-functional projects
Desired Qualifications
- Operational QA experience in analytical or manufacturing settings with experience with the following is preferred: Inspection support roles, Quality System background, conducting investigations, performing Root Cause Analysis and identifying CAPA, and/or Drug product (oral solid dosage forms preferred) development and manufacturing.
If you or someone you know may be interested, please send your resume to Lisa.Oster@PTSadvance.com or visit us at jobs.PTSadvance.com to learn more about the role. #LifeSciences #PTSAdvancejobs #PTSAdvance
