QA Investigations Lead – CAPA & Compliance

Hikma Pharmaceuticals; Bedford (OH); On-site; USD 60,000 - 120,000; Full time

Benefits offered by this job

Annual bonus & commission

401(k) with company match

20 days PTO

3 personal days

11 company holidays

Comprehensive health benefits

Employee discount program

Tuition reimbursement

Parental leave

Wellbeing rewards program

Job summary

Hikma Pharmaceuticals USA Inc. in Bedford, OH, seeks a Principal Investigator to lead investigations and manage CAPA activity across the QA function. You will supervise direct reports, review atypical events, and ensure timely disposition of affected batches within 30 days, coordinating with quality leaders and regulatory bodies as needed.

The role emphasizes strong cGMP expertise, FDA/EU audit familiarity, and effective cross-team collaboration to maintain compliance and product quality.

Qualifications

• Up to five years of pharmaceutical investigation experience.
• Knowledge of cGMP and FDA regulatory requirements.
• Experience with CAPA and investigations.

Responsibilities

• Lead and mentor investigation teams to meet CAPA timelines.
• Oversee deviations and classify events accurately.
• Review and approve investigations for critical complaints.
• Collaborate with QA, Regulatory, and Supply Chain.
• Communicate goals to stakeholders.
• Maintain QA investigation standards.

Skills

Investigation experience

cGMP

FDA audits

Quality systems

Regulatory compliance

Job description

Hikma Pharmaceuticals USA Inc. in Bedford, OH, seeks a Principal Investigator to lead investigations and manage CAPA activity across the QA function. You will supervise direct reports, review atypical events, and ensure timely disposition of affected batches within 30 days, coordinating with quality leaders and regulatory bodies as needed.

The role emphasizes strong cGMP expertise, FDA/EU audit familiarity, and effective cross-team collaboration to maintain compliance and product quality.