SalaryUSD TBD TBD
- Lead Functional Subject Matter Experts to define aligned processes for QS performance data collection, report, assessment and manage risks identified.
- Manage the implementation of key Continuous Improvement projects as needed.
- Implement and maintain processes aligned with applicable policies and standards to report on QS performance data, including monitoring of key leading and lagging indicators of QS performance as well as product performance.
- Administer Quality analytics processes and develop statistical analysis and reporting mechanisms for GXP systems and processes. To include systems to enhance monitoring, trending and signaling as relates to applicable data sources.
- Compile data and develop analysis to support Quality Management Reviews
- Lead contact for assistance in conducting establishing trending analysis of existing and new Quality System processes
- Provide input and support managing Quality system analysis documentation schedules and sample plans.
- Support the management of the Quality Systems Team as needed
- Active partner across CLIENT GXP groups, providing support and consultation
- Perform other related duties and special projects as required or requested.
- 4 to 8 years of experience in biopharmaceutical/pharmaceutical or related industry with strong background in statistics, data analytics or continuous improvement
- Hands-on experience as a project manager
- Lean/Six Sigma Green Belt certification
- Thorough knowledge of cGMPs, GXPs and Quality Systems required
- Working experience in risk management and or operational excellence
- Operations experience in a GMP environment a plus Proficiency with Microsoft Office Suite (Outlook, Excel, Word, etc.)
- Proficiency with statistical analysis methodologies and programs
- Strong interpersonal communication skills
- Passion for continuous improvement and demonstrated problem solving skills
- High attentiveness to detail
- Multifunctional experience to include operations management, quality system development and quality system analysis
- Bachelor's degree in biostatistics, life sciences or related field with strong background in statistics
- Advanced quality certification strongly desired (i.e., Six Sigma Green Belt, Certified Lean Expert, etc.).
- Peer Relationships
- Technical learning
- Action oriented
- Command skills
- Interpersonal savvy
- Customer focus
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