Quality Manager

• Provide subject matter expertise and accountability for Quality Risk Management (QRM) Program

• Provide QRM (ICH Q9 and ISO-14971) guidance and support to various cross-functional organizations.

• Facilitate risk analysis (FMEA, FMECA, PHA, HACCP and other equivalent accepted methods).

• Analyzes data from various sources (including, but not limited to: Non-Conformances, CAPAs, Deviations, Complaints, etc.) to identify and initiate QRM opportunities.

• Escalate critical risks identified during risk assessments to management.

• Perform Risk Analysis activities to ensure process and product shortcomings are identified and appropriately addressed (10 - 15%)

• Educate and train appropriate personnel on quality risk management practices and associated risk documentation requirements (10 - 15%).

• Maintain Risk Register process

• Coordinate the input process for new risks added into the Risk Register.

• Create periodic (monthly) management reports highlighting critical risk register events.

• Verify activity status of risk register events for closure with appropriate risk action owners.

• Escalate critical risk events to Management (immediate supervisor and others) (5 - 10%)

• Create Quality Risk Management standard operating procedures, such as; FMEA, PHA, HACCP, PHA, etc. as required (5%).

• Participate in regulatory agency inspections for Quality Risk Management initiatives.

• Author and review responses to inspection observations and agency questions pertaining to QRM (5%).

• Identify opportunities for continuous improvements and enhancement of QRM program to reflect current regulations and industry trends.

• Writing/Editing SOP’s

• Facilitate risk training sessions

• Facilitating SOP for Risk Assessment

• Finding someone to do Risk Assessment/Or doing risk assessment themselves

• Supporting regulatory inspections

• Assisting with work overflow with risk register activities