Operations Compliance Engineer

Operations Compliance Engineer

Requirements

• High school diploma / GED with minimum 8 -10 years’ experience (or) bachelor’s degree and minimum 3-5 years’ experience working in a Biopharma regulated cGMP environment.
• Excellent interpersonal and meeting/workshop facilitating skills
• Experience participating in risk assessments (REM, Comparison Matrix, FMEA, etc.).
• SMS / Lean / Six Sigma Experience required.
• Deep understanding of root cause analysis tools (GPS, Ishikawa/Fishbone, etc.) Deviation, CAPA, Change Control, SOP writing experience required.
• Solid working knowledge of MS Office (Word/Excel/PowerPoint)
• Project and Program Management experience required.

Responsibilities

• Work cross-functionally with subject matter experts to update and develop procedures across the entire site.
• Cooperates transversally to investigate and resolve distribution related customer (both internal and external) complaints.
• Use ERP systems to collect supply chain data to support investigations and recall management.
• Demonstrated ability to dissect a problem, understand the stakeholders and bring them to the table, collect the right data and present it in a way to effectively describe the right problem to solve, and skills needed to facilitate.
• Challenging discussions to identify the best solution to implement to eliminate the problem.
• Support department for internal and external audits.
• Uses Sanofi compliance enterprise systems to initiate and complete deviation investigations, CAPAs and related tasks.
• Works cross-functionally with SMEs to develop, initiate and manage change controls.
• Participates and develops metrics for Quality Council Meetings.
• Represents department as SME for meetings.
• Facilitates deviation investigation meetings with SMEs to complete root cause analysis and identify corrective and preventative actions.
• Facilitates in daily metric discussions at the Gemba to include KPI’s, trending, and pareto analysis of daily business drivers.
• Recommends and develops ideas for improvement in operating methods and procedures to resolve problems prior to or when they arise.
• Strong project and program management skills. Able to mentor/teach others.
• Effective at providing feedback to peers inside and outside of direct organization.

Preferred Qualifications

• Bachelor’s degree in science or engineering related fields
• PMP certification and/or master’s degree.
• Experience using graphic design software to create and edit graphics and videos.
• Participation in external cGMP regulatory audits.
• Experience creating workspaces using SharePoint.