• Organize, lead, and facilitate cross-functional investigation teams.
• Drive investigations for quality deviations forward in an active and leading role.
• Conduct quality investigations with focus on performance improvement and risk reduction, in alignment with the Pharmaceutical Quality System requirements and governing regulations.
• Document investigation findings in reports and designated quality systems and ensure required management and quality approvals on final investigations while satisfying established due dates.
• Facilitate internal sharing of investigational findings and risk knowledge. Contributes to metrics related to investigation process and CAPA effectiveness.
• Present ongoing investigation status to customers.
• Presents investigations during internal and external audits and inspections.

• B.S. / M.S. degree in Engineering, Forensics, or a related scientific discipline.
• Knowledge in drug substance and/or Drug product manufacturing is an advantage.
• 1-2 years of experience (industrial/plant experience preferred).
• Experience in performance improvement with basis in Human and Organizational Performance principles.
• Practical knowledge and application of c GMP, c GLP, EMEA and experience interfacing with customers, inspectors, investigators and/or agency personnel.
• Strong technical writing skills and ability to synthesize information from multiple SMEs into a coherent, clear and concise narrative.
• Effective facilitation skills to internal stakeholders, customers and senior management.
• Experience in management of diverse stakeholders with strong interpersonal/influencing skills.
• Ability to balance resource demands from multiple internal stakeholders.
• Demonstrated ability to analyze, extrapolate data, synthesize and determine recommendations, including the analysis of complex problems.
• Strong verbal and written English communication skills and comfortably and clearly articulate issues across the organization and to customers.
• Experience with customer interface is an advantage.

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