• Lead investigations for critical, high-risk Quality and Safety deviations and incidents. Conduct Quality and Safety investigations with focus on performance improvement and risk reduction, in alignment with Quality Management System requirements and governing safety regulations. Lead complex and/or high impact investigations, including those with product impact. Identifies root and contributing causes and make recommendations to correct and/or prevent recurrence.    
• Document investigation reports and findings in designated Quality and Safety systems. Ensure required management and Quality approvals on final investigations while satisfying established due dates. Facilitate corrective and preventive action agreement with stakeholders.
• Facilitate internal sharing of investigational findings and risk knowledge.  Contribute to metrics related to investigation process and CAPA effectiveness.
• Coach junior staff on investigative techniques and mentor Lead Investigators and Investigators. Provide training on various roles related to investigations as required. Develop metrics reports for presentation to Senior Leadership.
• Present investigations during internal and external audits. Conduct internal self-audits of investigations and identified continuous improvement actions.

• B.S./Master’s degree in Engineering, Organizational Psychology, Industrial Safety, Forensics or a related scientific discipline
• A minimum of 8-10 years of experience in a lab and operations environment (industrial/plant experience preferred)
• Demonstrated experience in systematic cause analysis methods, including Event & Causal Factor charting, Logic Fault Tree and similar techniques.
• Expert facilitation skills and proven record to effectively lead cross-functional teams.
• Expert technical writing skills and ability to synthesize information from multiple SMEs into a coherent, clear and concise narrative.
• Ability to interpret technical information and documentation used for operations and production activities.
• Experience in management of diverse stakeholders with strong interpersonal/influencing skills. Ability to communicate effectively across organizations. Ability to balance resource demands from multiple internal customers.
• Demonstrated experience in performance improvement with basis in Human and Organizational Performance principles.  
• Practical knowledge and application of cGMP, cGLP, EMEA, and OSHA compliance regulations and inspections plus experience interfacing with inspectors, investigators and/or agency personnel.
• Strong interpersonal skills including the ability to negotiate and resolve challenges with poise, tact and diplomacy.
• Strong oral and written communication skills to all employment levels and to PO&T Senior Leadership.
• Demonstrated ability to analyze, extrapolate data, synthesize and determine recommendations, including the analysis of complex problems.

The Senior Investigator is responsible for maximizing organizational learning and improvement from critical, high-risk Quality and Safety deviations. The incumbent applies systematic and analytical cause analysis techniques inclusive of Human and Organizational Performance principles to each investigation assigned. The Senior Investigator identifies the best methodology for the given situation, facilitates investigation team meetings, conducts interviews, and collects and synthesizes data in order to identify causes that if addressed would prevent recurrence. The Senior Investigator will facilitate Learning Teams as a collaborative approach to support cause analysis. Investigations assigned to the Senior Investigator are those with highest level of complexity and may require global stakeholder engagement. The incumbent partners with stakeholders from all areas of the business to ensure actions taken as a result of findings prevent or mitigate the risk of future recurrence. The incumbent ensures effective communications to stakeholders and manages activities to ensure completion per expected regulatory and product release timelines. The incumbent ensures investigations are conducted in alignment with Quality Management System requirements and governing safety regulations, and presents investigative findings during audits as requested.