Pharma Compliance & Internal Audit Lead

Allergan; Waco (TX); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking an Internal Audit Specialist to implement and maintain a functional internal audit system ensuring production and support functions comply with applicable regulations and standards at the manufacturing facility.

You will lead regulatory compliance audits (DEA, FDA), prepare written reports, track CAPAs, and communicate requirements to plant personnel while aligning with GMPs and plant quality initiatives.

Qualifications

• Bachelor’s Degree in Science or Engineering or equivalent related work experience.
• 3+ years of Biopharmaceutical experience.
• Quality Assurance/Regulatory Affairs/Compliance experience required.
• Knowledge of regulations and standards for pharmaceuticals (CFR, MCA, DEA).
• Able to evaluate quality, production and support areas for compliance to GMPs.

Responsibilities

• Plan and conduct internal compliance audits of all operations within the facility.
• Serve as plant administrator for inspections by regulators (DEA, FDA).
• Report violations to plant management in audit wrap-up meetings.
• Follow up on audits to ensure corrective actions are completed.
• Disseminate regulatory requirements to plant personnel.
• Coordinate and facilitate major plant quality improvement projects.

Skills

Regulatory compliance

Audit execution

Decision making

Communication

Education

Bachelor's Degree (Science/Engineering)

Job description

AbbVie is seeking an Internal Audit Specialist to implement and maintain a functional internal audit system ensuring production and support functions comply with applicable regulations and standards at the manufacturing facility.

You will lead regulatory compliance audits (DEA, FDA), prepare written reports, track CAPAs, and communicate requirements to plant personnel while aligning with GMPs and plant quality initiatives.