Manager, Research & Development Quality, Quality Management System (Contract)
Precision Life Sciences
Cambridge , MA 02138
Posted 2 months ago
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We are working with a client, in the life sciences industry, that is seeking a Manager, Research & Development Quality, Quality Management System (QMS) who will be responsible to assist with the development and ongoing support of the QMS for the Research and Development organization including but not limited to GxP (GLP, GCP, GVP & CSV) Policies and Procedures, Knowledge Management, Issue Management, Metrics, and Reporting.
Heres What Youll Do:
- Participate in the establishment and support of the formalized R&D QMS by:
- Collaborating with R&D colleagues to assess/support the state of the R&D QMS by evaluating the major elements for both the current state and as part of the ongoing assessment of the QMS for continuous improvement.
- Identify critical processes and associated key quality metrics with R&D colleagues across GxPs (GLP, GCP, GVP, and CSV) and functional areas (Clinical Operations, Safety, Regulatory, Nonclinical, etc.)
- Work with the RDQ-QMS metrics role to collect and evaluate R&D key quality metrics in an ongoing fashion for quality management reporting.
- Support R&D colleagues with issues raised as part of assessing the QMS and as part of any proactive continuous improvement activities/initiatives.
- Work with RDQ colleagues to identify and collect critical Inspection, Audit, Issue Management, and Program support quality metrics as part of the quality management reporting process
- Work to harmonize the process with the Global QMS team where appropriate.
- Participate in initiatives/meetings which require R&D QMS support.
- Provide support for additional RDQ deliverables, as needed
Heres What Youll Bring to the Table:
- BS/BA with 8 to 10 years of experience or MS with 5 to 8 years of experience or Ph.D. with 0 to 2 years of experience in pharmaceutical/biotech industry with experience in the R&D GCP/GLP/ GVP environment
- Demonstrated knowledge and/or prior experience with a clinical QMS (Transcelerate model of the clinical QMS preferred)
- Outstanding communication skills (verbal and written)
- Ability to manage multiple projects in a fast-paced environment.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Ability to make decisions that are guided by policies, procedures, and business plans; receives guidance and oversight from manager.
- Relies on experience and judgment to plan and accomplish goals.
- Excellent organizational skills and keen attention to detail.