Compliance Officer (Inspection Coordinator)

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

Compliance Officer (Inspection Coordinator)

• Full-time
• Salary Min: 96500
• Salary Max: 183500
• Workday Global Grade: 17
• Compensation: USD 96500 - USD 183500 - yearly

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com . Follow @abbvie onLinkedIn, Facebook ,Instagram ,X andYouTube.

Responsible for implementing and maintaining a functional internal audit system that will assure that all production and support functions at the manufacturing facility operate in compliance with all applicable regulations and standards.

Responsibilities

• Responsible for Regulatory Compliance at the plant level which includes planning and conducting internal compliance audits of all operations within the facility.
• Serve as plant administrator for all company and regulatory agency (i.e. DEA, FDA) inspections.
• Convey all violations to appropriate plant management/supervisory personnel via written reports and/or open discussions in audit wrap-up meetings.
• Follow up on audits to assure that action plans are developed and completed in a timely fashion.
• Keep current with all regulatory requirements and disseminate and interpret all regulatory requirements to plant personnel in a timely and accurate fashion.
• Consult with plant personnel on regulatory requirements and compliance related topics.
• Responsible for management review and associated metrics for the plant
• Administrate/coordinate the plant manufacturing materials and pest control programs.
• Coordinate and facilitate major plant quality improvement projects at the plant or company level.
• Perform process of metrics collection and analysis for compliance-related corrective and preventive actions (CAPA’s)

• Bachelor’s Degree, preferably in Science or Engineering, or equivalent related work experience is required.
• 3+ years of Biopharmaceutical experience
• Quality Assurance/Regulatory Affairs/Compliance experience required
• Knowledge of regulations and standards for pharmaceuticals (e.g. CFR, MCA, DEA).
• Able to demonstrate extensive knowledge of plant and company level procedures.
• Ability to evaluate quality, production and support areas for compliance to GMPs. BOPs, etc.
• Strong decision making
• Ability to anticipate problems, identify and investigate them, and make recommendations to help resolve

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified in thefuture.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

This job is eligible toparticipate in our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified at the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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