Manager, Quality Analytics & Systems

Is your career in its prime?  It could be!

YPrime's Quality & Compliance teamissearching for a 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