Officer, Compliance II

Company Description

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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Execute Compliance area activities related to compliance projects, inspections (external, internal, customers), and regulatory submission documentation.

Responsibilities

• Responsible for conducting a comprehensive internal audit program and ensures that the Internal Audit system is effectively implemented. The incumbent must work closely with the QA Director in the handling of external regulatory inspections and on the resolution of regulatory compliance issues.

• Assists in the development, implementation and continuous improvement of the Internal Audit System and utilizes audits and consultations as a training vehicle to increase awareness of Compliance expectations.

• Monitors and maintains plant compliance with Operations and regulatory/applicable standards requirements.

• Participates in the training of the Internal Audit Team to ensure their knowledge in BOP's, GMP regulations, Operations and Site policies and procedures.

• Audits systems such as: documentation, change control, calibration and preventive maintenance. Also responsible for auditing GLP's and practices, test procedures, and other related documentation.

• Plans and performs internal quality audits of all plant operation, including pre-approval inspection audits and quality system standards, equipment, and all other aspects of the plant’s quality system for compliance with Operations, procedures and applicable regulations, such as FDA cGMP & MHRA regulations/ guidelines, DEA regulations and Puerto Rico Department of Health (Administración de Servicios de Salud Mental y Contra la Adición ASSMCA) as well as serving as escort during Regulatory and

• Assures that quality issues are addressed in conformity with regulatory agencies such as Food and Drug Administration (FDA), the Drugs Enforcement Agency (DEA), Administración de Servicios de Salud Mental y Contra la Adiccion (ASSMCA), Korean FDA, European Agency for the Evaluation of Medicinal Product (EMEA) and the Medicines Healthcare Products Regulatory Agency (MHRA), Mexican Ministry of Health (COFEPRIS), Agencia Nacional de Vigilancia Sanitaria de Brazil (ANVISA) and internal/Operations

• Maintains a corrective action system oriented towards the prompt resolution of quality / regulatory problems identified through internal and external sources of quality data.

• Participates in Operations Compliance, regulatory, third party and client audits as facilitator, back room support. Track and follow up all audit commitments from GMP regulatory agencies, AQR, DEA, ASSMCA, Third Parties and clients and plant Internal Audits. Schedules meetings with senior plant management to discuss audits observations.

• Assists in the implementation of major projects, for achieving an effective and efficient performance that meets Plant and Quality Operations plans for supporting marketing demand. Conform to EH&S management system requirements, promote continuous improvement, and consider EH&S aspects during the design and change process.

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Frequent to continuous computer usage (greater or equal to 50% of the workday) is required

Qualifications

• Bachelor's Degree in a Science or Engineering field.

• Formal training in Quality System Auditing.

• Six (6) years of experience in Quality Assurance/Regulatory or compliance.

• A thorough Knowledge of regulations and standards affecting Pharmaceutical Products (i.e. CFR 210/211, cGMP, Quality Systems, FDA and DEA regulations).

• Auditing experience. Requires direct experience with FDA, DEA, and European regulations and experience in government inspection and audit techniques at least two (2) years.

• Total combined minimum years of experience required 6 years.

• Experience within the Pharmaceutical, Biologics or Medical Devices industry is highly desired.

Additional Information

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

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount isearned, vested, anddeterminable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolutediscretion, 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html