Quality Systems Manager
121 Seaport Boulevard Boston, MA 02210
Position: Quality Systems Manager
Location: South San Francisco, CA; Boston, MA; or New Haven, CT – remote until further notice
Job Type: Contract
Duration: 5 months
Our client is seeking a Full Time Manager, Quality Systems, to join the Quality Scaled and Digital Services team. This role will interface globally with users across Global Operations, Commercial, Research & Development, IT and Quality to support execution and monitoring of the enterprise Quality Management System (QMS) governing Deviation, CAPA and Change Control.
- Use deep process knowledge and experience to assist business partners with the 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 (audits, visual management systems, dashboards, status reports etc.).
- On-time completion of assigned projects.
- Author, review and approve QMS procedural documentation and working practice documents.
- Create and deliver Quality Systems training (process and technical).
- Participate in inspection readiness activities and internal/external audits and inspections.
- Other duties as required to support the growing Quality organization.
- 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.
- Excellent communication skills with all levels of the organization and Health Authority representatives.
- Able to prioritize and manage workload and manage shifting priorities based on criticality to ensure commitments are met.
- Direct experience with TrackWise desired.
- Bachelor’ s degree in a technical or life sciences discipline (ex. Chemistry, Biology, Biotechnology)