• Prioritize and level-load the Investigation Team’s work to enable timely decisions and on-time completion of investigations; escalate issues as appropriate.

• Guide the site on deviation standards and drive improvements to investigation processes.

• Lead cross-functional investigations to root cause, selecting and applying approved problem-solving tools to keep the team on schedule.

• Direct organized investigations with a defined scope, strategy, and timeline, documenting the status and progress of the investigation and associated CAPAs.

• Align cross-functional partners on communication and investigation strategy, a clear and actionable problem statement, root cause, solution selection, and the CAPA action plan and effectiveness checks.

• Work within and across sites to connect investigations across functional areas.

• Promote continuous improvement in quality, efficiency, production, and safety through team-driven processes, key performance indicators, and recognition of high performance.

• Seek and leverage internal and external expertise to improve the speed and rigor of investigations.

Documentation & Compliance

• Serve as Business Process Owner (BPO) for Investigations, maintaining investigation procedures, standards, and metrics and representing the site in relevant cross-site forums.

• Maintain deviation metrics and report on investigation performance.

• Author investigation reports that document the problem definition, scope, product impact, root cause, and corrective actions to prevent recurrence.

• Partner with Quality to ensure efficiency, rigor, and sound risk management across investigation processes.

Training & Development

• Coach, train, and develop direct reports to optimize performance and ensure each person understands the contribution they make.

• Lead the Investigation Team with a focus on people management and coaching to build and sustain a high-performing, diverse organization.

• Serve as the site’s subject-matter expert (SME) and trainer in problem-solving and root cause analysis, educating contributors on investigation processes.

• Experience in pharmaceutical manufacturing or another similar regulated industry, including leadership or people-management experience.

• Ability to assess and assimilate technical data, conduct thorough investigations, and identify the critical factors needed to generate effective, risk-appropriate solutions.

• Excellent technical writing and verbal communication skills, with the ability to present findings, conclusions, and complex information in a clear, concise, and logical manner.

• Thorough understanding of core business processes, including relevant cGMP and regulatory requirements.

• Ability to prioritize and manage multiple activities in a fast-paced, rapidly changing environment to meet objectives, customer needs, and deadlines.

• Accountability and strong follow-through, owning issues through the full investigation cycle.

• Professional presence, with the ability to confidently engage all levels of leadership.

• Degree in technical, healthcare, regulatory compliance, or other relevant discipline.

• 10+ years in pharmaceutical manufacturing or another similar regulated industry, including progressive management experience.

• Multi-site and/or multi-function experience, including directing and participating in cross-functional teams.

• Experience in a LEAN manufacturing environment and with Lean problem-solving tools.

• Project management skills.

• Proficiency with Microsoft Office Suite and working knowledge of, or the ability to learn, systems such as SAP, LIMS, and Electronic Batch Record systems.