Senior Manager, Investigations
$125,000–$181,250 year
On-siteWest Chester, Ohio, United States
Job Summary
Prioritize and level-load the Investigation Team's work to enable timely decisions and on-time completion of investigations, escalating issues as appropriate. Lead cross-functional investigations to root cause, selecting approved problem-solving tools to keep the team on schedule while documenting status and progress. Guide the site on deviation standards, drive process improvements, and align partners on communication strategies, root causes, and CAPA action plans. Serve as Business Process Owner for Investigations, maintaining procedures, metrics, and reports while representing the site in cross-site forums. Coach the team on problem-solving tools, optimize performance, and build a high-performing organization. Partner with Quality to ensure rigor and sound risk management across investigation processes.
Required Qualifications
- Experience in pharmaceutical manufacturing or another similar regulated industry
- Leadership or people-management experience
- Ability to assess and assimilate technical data
- Ability to conduct thorough investigations
- Ability to identify the critical factors needed to generate effective, risk-appropriate solutions
- Excellent technical writing skills
- Excellent verbal communication skills
- Ability to present findings, conclusions, and complex information in a clear, concise, and logical manner
- Thorough understanding of core business processes
- Understanding of relevant cGMP and regulatory requirements
- Ability to prioritize and manage multiple activities in a fast-paced, rapidly changing environment
- Accountability and strong follow-through
- Professional presence
- Ability to confidently engage all levels of leadership
Desired Qualifications
- Degree in technical, healthcare, regulatory compliance, or other relevant discipline
- 10+ years in pharmaceutical manufacturing or another similar regulated industry
- Progressive management experience
- Multi-site and/or multi-function experience
- Experience directing and participating in cross-functional teams
- Experience in a LEAN manufacturing environment
- Experience with Lean problem-solving tools
- Project management skills
- Proficiency with Microsoft Office Suite
- Working knowledge of, or the ability to learn, systems such as SAP, LIMS, and Electronic Batch Record systems
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