Job Description
At YPrime, we help our clients in the pharma and biotech industries to collect data from patients using mobile devices, assign patients to study treatment groups, and dispense clinical trial drugs and supplies using web apps. We're supporting life-altering research, one project at a time.
Is your career in its prime? It could be!
YPrime's Quality & Compliance teamissearching for a Senior Manager, Quality Analytics & Systems. You'll be basedin one of our Malvern, PA; Raleigh, NC; or Sandwich, Kent offices.
Does our mission sound like something you can get behind? If so, here's what we need from you:
- 4+ years of experience in data science
- Experience providing and presenting metrics at an organizational level
- Excellent client-facing communication skills with ability to manage issue escalations, conflict negotiations, and influence
- Proficiency with data mining, mathematics, and statistical analysis
- Demonstrated understanding of computer system validation, CAPA (Corrective and Preventative Action), Deviation Documentation, and Auditing
- Experieince utilizing Power BI, Excel, Word, PowerPoint, SQL, Jira, Tableau, or other programming and reporting technologies
Here are some more details about the job:
- You'll provide leadership to the Quality & Compliance Analytics and Systems team, setting a strategic direction for the departments data analytical needs and Electronic Quality Management System (eQMS).
- You'll serve as the lead quality data strategist for Quality & Compliance to identify and integrate new datasets that can be leveraged to identify quality and compliance metrics.
- You'll identify and Establish systems and data structures to collect large amounts of data using analytical, statistical, and programmable skills.
- You'll devise and utilize algorithms and models to mine big-data stores; perform data and error analysis to improve models; clean and validate data for uniformity and accuracy
- You'll analyze data for trends and patterns, and interpret data with clear objectives in mind
- You'll work with YPrime study teams to create client dashboards with key Quality performance indicators (YPrime related) along with any client requested information (requested KPI (Key Performance Indicators), metrics, etc.)
- You'll perform trending analysis based on performances on past projects; project trends to number of CCFs (Change Control Form), Deviations, CAPAs (Corrective Actions and Preventive Actions), etc.
- You'll keep dashboards updated based on current industry landscape
- You'll create internal Quality dashboard with applicable metrics and dive down detail as needed
- You'll perform root cause investigations on data anomalies/missed targets and provide corrective/preventive recommendations
- You'll coordinate data fluidity between systems, where needed (i.e., LMS, Veeva Vault, PPM Pro, etc.)
- You'll identify applicable data points to capture in associated systems (i.e., properties in Veeva Vault, PPM Pro, LMS, JIRA) for future analysis needs
- You'll provide analytical and/or technical training to the team as needed
- You'll serve as an administrator of all Quality tools (i.e., Jira, Veeva, etc.)
- You'll manage the performance of direct reports
Have these things too? Even better!
- Bachelor's degree (or equivalent) in statistics, applied mathematics, a related discipline, or an equivalent amount of related experience
- Experience working in an FDA regulated industry
What are the YPrime Perks?
- Generous paid time off
- Comprehensive benefits package largely subsidized by YPrime
- 401(k) with company match
- Flexible working arrangements with an emphasis on work/life balance
- Friendly, smart, passionate and hard-working coworkers
- Opportunities for professional growth and advancement