Senior Manager, Investigations

Resilience•West Chester, OH

2d•$125,000 - $181,250•Onsite

About The Position

The Senior Manager, Investigations leads the site team that conducts investigations in support of Deviations and Complaints, ensuring investigations and root cause analyses are completed in an effective, compliant, and timely manner. As the subject-matter expert (SME) in problem-solving and root cause analysis, they set team standards and priorities, coach the team on appropriate tools, and guide the identification of true root causes and risk-appropriate corrective and preventive actions. As Business Process Owner (BPO) for Investigations, they maintain procedures and metrics, represent the site in cross-site forums, and partner with Quality to ensure rigor and sound risk management.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.
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.
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.