Compliance Officer I

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Title: Officer, Compliance I

Purpose:

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.
•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 Adicción ASSMCA) as well as serving as escort during inspections.
•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).
•Reviews the acceptability of Corrective and Preventive Action (CAPA) resulting from audit observations. Reconciles CAPA inadequacies with audited area. 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. Schedule meetings with senior plant management to discuss audits observations.
•Works with Compliance Officer II in all Compliance and Regulatory activities applicable to the site.
•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.
•Responsible for executing assigned tasks as required by the operational area. Conform to EH&S management system requirements, promote continuous improvement, and consider EH&S aspects during the design and change process.

Qualifications

Qualifications:

• Bachelor's Degree in a Science or Engineering field.
• Two (2) years of experience in Quality Assurance/Regulatory or compliance.
• General knowledge of regulations and standards affecting Pharmaceutical Products (i.e. CFR 210/211, cGMP, Quality Systems, FDA and DEA regulations).
• Experience with Regulatory Agency requirements (e.g., FDA, DEA), experience in government inspection and audit techniques at least one (1) year.
• Because the role requires working directly with the Internal Audit program, it is essential that candidates are available to work in person at the plant.
• Candidates must have knowledge in manufacturing (API, biologics, filling, sterile production) 

Key Stakeholders:

QA organization, Manuacturing, Engineering.

Significant Work Activities
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.