Senior QA Investigation Lead

Hikma Pharmaceuticals; Bedford (OH); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

PTO 20 days

Personal days

Health, dental, vision insurance

Employee discount

Career growth

Parental leave

Job summary

Hikma Pharmaceuticals USA Inc. seeks an experienced QA professional to lead investigations across the QA, Regulatory, and Supply Chain functions. You will mentor investigators, assess events, and ensure CAPA disposition within 30 days to maintain quality and compliance.

Candidates should have strong cGMP knowledge, FDA/audit experience, and excellent communication and leadership skills in a fast-paced pharmaceutical environment.

Qualifications

• Experience in pharmaceutical quality systems and investigations.
• Knowledge of cGMP, FDA audits, and EU regulatory requirements.
• Strong analytical, root-cause analysis and CAPA capabilities.
• Excellent communication and leadership skills under regulatory scrutiny.
• Ability to plan, organize, and manage multiple investigations.

Responsibilities

• Lead, coach, and mentor investigation teams (QAI and Product Complaints).
• Review and approve investigations, focusing on CAPA and disposition within 30 days.
• Escalate quality and compliance issues to leaders as appropriate.
• Coordinate with QA, Regulatory, and Supply Chain to ensure compliant investigations.
• Maintain QA investigation standards, processes, and training sustainability.

Job description

Hikma Pharmaceuticals USA Inc. seeks an experienced QA professional to lead investigations across the QA, Regulatory, and Supply Chain functions. You will mentor investigators, assess events, and ensure CAPA disposition within 30 days to maintain quality and compliance.

Candidates should have strong cGMP knowledge, FDA/audit experience, and excellent communication and leadership skills in a fast-paced pharmaceutical environment.