Investigation Leader, Quality & CAPA

Resilience; Olde West Chester (OH); On-site; USD 125,000 - 181,000; Full time

Benefits offered by this job

Annual bonus

401(k) plan with company match

Healthcare benefits

Paid vacation

Tuition reimbursement

Job summary

Resilience in Ohio seeks a Senior Manager, Investigations to lead the on-site team responsible for deviations and complaints, ensuring robust root cause analyses and timely CAPA actions.

As the SME in problem-solving, you will set standards, coach staff, and partner with Quality to maintain rigorous risk management while guiding investigations across cross-functional partners to improve processes and outcomes.

Qualifications

• Experience leading investigations in regulated manufacturing or pharma.
• Ability to synthesize complex data into concise findings and actions.
• Strong written and verbal communication with cross-functional partners.

Responsibilities

• Prioritize Investigation Team workload and ensure timely completion.
• Guide deviation standards and improve investigation processes.
• Lead cross-functional investigations using approved problem-solving tools.
• Document investigation scope, strategy, and CAPA plan and effectiveness checks.
• Coordinate with cross-site partners on communication and strategy.

Skills

Leadership

Root Cause Analysis

Problem Solving

Regulatory Compliance

Cross-functional Leadership

Process Improvement

Education

Bachelor's degree in technical/regulated field

Tools

SAP

LIMS

Electronic Batch Records

Job description

Resilience in Ohio seeks a Senior Manager, Investigations to lead the on-site team responsible for deviations and complaints, ensuring robust root cause analyses and timely CAPA actions.

As the SME in problem-solving, you will set standards, coach staff, and partner with Quality to maintain rigorous risk management while guiding investigations across cross-functional partners to improve processes and outcomes.