Senior Manager, Investigations & Quality Leadership

Resilience; Northern (KY); Hybrid; USD 125,000 - 181,000; Full time

Job summary

Resilience is seeking a Senior Manager, Investigations to lead site investigations supporting deviations and complaints. You will define scope, guide cross‑functional teams and ensure timely completion of investigations with robust CAPA plans and risk-based actions.

You will mentor staff on problem‑solving tools, maintain procedures, and partner with Quality to enforce rigorous risk management across investigation processes.

Qualifications

• Experience in pharmaceutical manufacturing or another regulated industry with leadership experience.
• Ability to assess technical data, conduct investigations, and identify critical factors for solutions.
• Excellent technical writing and verbal communication skills to present findings clearly.
• Thorough understanding of core business processes, including cGMP and regulatory requirements.
• Ability to prioritize and manage multiple activities in a fast-paced environment; accountability.

Responsibilities

• Prioritize and level-load the Investigation Team’s work to enable timely decisions; escalate issues as needed.
• Guide the site on deviation standards and drive improvements to investigation processes.
• Lead cross-functional investigations to root cause, applying approved problem‑solving tools to stay on schedule.
• Direct organized investigations with a defined scope, strategy, and timeline; document status and CAPAs.
• Align cross-functional partners on communication and strategy, a clear problem statement, root cause, solution, and CAPA plan.
• Work within and across sites to connect investigations across functional areas.
• Promote continuous improvement in quality, efficiency, production, and safety via KPIs and recognition.
• Seek internal and external expertise to improve investigation speed and rigor.

Skills

People management

Root cause analysis

Technical writing

Regulatory compliance

Cross-functional leadership

Prioritization

Education

Bachelor's degree (technical/healthcare/regulatory)

Tools

SAP

LIMS

Electronic Batch Records

MS Office

Job description

Resilience is seeking a Senior Manager, Investigations to lead site investigations supporting deviations and complaints. You will define scope, guide cross‑functional teams and ensure timely completion of investigations with robust CAPA plans and risk-based actions.

You will mentor staff on problem‑solving tools, maintain procedures, and partner with Quality to enforce rigorous risk management across investigation processes.