Associate Director, Investigations Excellence & Inspection Readiness

Here's What You'll Do

• Own and continuously improve the effectiveness, quality, consistency, and rigor of investigations across the site, ensuring investigations drive meaningful learning and systemic improvement and recurrence prevention rather than administrative closure.
• Lead complex, cross-functional investigations and systemic problem-solving efforts that span multiple organizations.
• Lead the site's approach to CAPA effectiveness by ensuring corrective and preventive actions address systemic issues, reduce risk, improve performance, and deliver sustainable results.
• Partner with Manufacturing Operations, Logistics, Manufacturing Support, Quality, Manufacturing Technology & Digital Operations, DNA, and Strategy & Intelligent Operations to improve reliability, prevent recurrence, and strengthen operational performance.
• Build organizational capability in investigation excellence, root cause analysis, and systemic problem solving through coaching, training, mentoring, and standardization of best practices.
• Own and improve site governance processes including Investigation Reviews, CAPA Effectiveness Reviews, Recurrence Reduction Reviews, Site Learning Reviews, Operational Risk Reviews, and Management System Health Reviews.
• Act as a site leader using data, trend analysis, and operational insights to identify opportunities for performance improvement, risk reduction, operational simplification, and increased organizational effectiveness.
• Lead the site's continuous Inspection Readiness program in partnership with Quality Assurance, adapting the program based on regulatory intelligence, site risks, and evolving business needs.
• Translate regulatory intelligence, inspection trends, and site risks into proactive readiness priorities, assessments, and improvement actions that strengthen compliance and reduce inspection risk.
• Build site-wide inspection capability through routine readiness assessments, inspection simulations, coaching, and preparation of leaders and subject matter experts to effectively support regulatory inspections.
• Build and lead a high-performing team capable of serving as trusted advisors, investigators, problem solvers, and change agents across the Norwood organization.

Here's What You'll Need

• Bachelor's degree in a technical discipline.
• 10+ years of biopharmaceutical, manufacturing, quality, technical operations, or operational excellence experience.
• Experience leading investigations, CAPA, root cause analysis, or operational improvement programs in a GMP environment.
• Experience with GMP inspection readiness.
• Direct inspection experience preferred.
• Strong understanding of manufacturing operations, quality systems, and continuous improvement methodologies.
• Proven leadership, stakeholder influence, and change management experience.