ACCELERATING YOUR FUTURE The Principal, QA - Quality Systems is responsible for providing QA oversight of Quality Systems and Computer System Validation. This includes supporting review and approval of new Computer System Validation deliverables, governing procedures and training content for computerized systems, as well as supporting maintenance and optimization of software systems and computerized equipment. The ideal candidate has extensive Quality Systems experience in a GMP environment and experience in Computer System Validation in accordance with GAMP.
HOW YOU WILL MAKE AN IMPACT- Support optimization Quality Management Systems electronic workflows such as Deviations, Change Controls, CAPAs, Internal Audits, Client Audits and Inspections
- Support implementation of GMP software systems through review and approval of Computer System Validation deliverables.
- Support ongoing maintenance and upgrade to existing systems.
- Lead site Data Integrity initiatives
- Support the evaluation of systems for compliance with 21 CFR Part 11 and Annex 11.
- Optimize workflows and support updates to standard operating procedures and learning content for the Quality Systems Programs.
- Support monitoring of implementation of Quality System Programs, ensuring compliance to SOPs and identifying areas for improvement
- Support implementation and QA training to new systems
- Review/Approve Deviations, Change Controls and CAPAs as necessary (as is pertains to CSV, Data Integrity, Quality Management Systems, etc)
- Mentor personnel within QA and cross functionally on Quality Systems to promote a quality culture
- Support internal audits and GMP readiness (as assigned)
- Support Health Authority Inspections and Client Audits including audit responses and CAPAs
WHAT YOU WILL BRING- 8+ years relevant Quality Assurance experience in a pharma/biotech company, working within a Quality System and regulated GMP environment. Cell therapy experience a plus
- 3+ years Software Validation QA experience.
- Prior experience with implementing quality systems and/or continuous improvement initiatives focused on quality systems
- Ability to partner cross functionally and integrate feedback during development and implementation of quality systems
- Ability to work independently to meet objectives and timelines
- Ability to make decisions of moderate complexity independently and escalate complex decisions as needed.
- Understanding of cGMP and ICH regulations/guidelines
