Compliance & Inspection Lead (GMP/Regulatory)

ABBVIE; Waco (TX); On-site; USD 97,000 - 184,000; Full time

Benefits offered by this job

PTO

Health insurance

401(k)

Job summary

AbbVie in the United States seeks a Compliance Officer (Inspection Coordinator) to lead regulatory audits at the manufacturing facility and coordinate DEA/FDA inspections. You will ensure GMP compliance, report violations, and drive timely CAPA actions to sustain a robust compliance program.

You will maintain up-to-date regulatory knowledge, advise plant personnel, and support quality improvement initiatives across the site.

Qualifications

• Bachelor’s Degree in Science or Engineering or equivalent related work experience are required.
• Strong knowledge of regulations and standards for pharmaceuticals (CFR, MCA, DEA).
• Ability to evaluate quality, production and support areas for GMP/compliance.

Responsibilities

• Plan and conduct internal compliance audits of all operations within the facility.
• Serve as plant administrator for all company and regulatory inspections (DEA, FDA).
• Convey all violations to plant management via written reports or audit wrap-up discussions.
• Follow up on audits to ensure action plans are developed and completed timely.
• Keep current with regulatory requirements and disseminate them to plant personnel.
• Consult with plant personnel on regulatory requirements and compliance topics.
• Manage review and metrics for the plant.
• Administer plant manufacturing materials and pest control programs.
• Coordinate and facilitate major plant quality improvement projects.

Skills

Decision making

Regulatory compliance knowledge

Auditing

Analytical skills

Education

Bachelor’s Degree in Science or Engineering

Job description

AbbVie in the United States seeks a Compliance Officer (Inspection Coordinator) to lead regulatory audits at the manufacturing facility and coordinate DEA/FDA inspections. You will ensure GMP compliance, report violations, and drive timely CAPA actions to sustain a robust compliance program.

You will maintain up-to-date regulatory knowledge, advise plant personnel, and support quality improvement initiatives across the site.