Hispanic Alliance for Career Enhancement
Future Opportunities - Join Our Talent Pipeline for Finance Lead, Audit
Hispanic Alliance for Career Enhancement, North Chicago, Illinois, us, 60086
Company Description
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 - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.
Job Description Thank you for considering a future opportunity with our company! We are currently not hiring for this specific role, but we would love to connect with talented individuals interested in potential future positions. By joining our talent pipeline, you will be the first to be notified when suitable opportunities arise.
This requisition is for building a network of exceptional individuals with the skills and experience required for future openings. By submitting your application, you will be added to our talent pipeline and considered for upcoming opportunities.
Qualifications Purpose The function of Audit and Compliance Senior Auditor/Lead is to perform comprehensive audits for compliance with US and foreign regulation requirements, providing constructive evaluation of quality-related systems for AbbVie plants, affiliates, quality service areas, and/or suppliers. The role ensures activities are performed and documented in accordance with AbbVie policies/procedures and applicable quality and regulatory requirements, maintaining the quality, effectiveness, and safety of our products. This position requires a balance of involvement and objectivity.
Responsibilities
Assess compliance of systems, facilities, and procedures per applicable regulations, ensuring adherence to regulatory requirements and AbbVie specifications.
Provide feedback through audit observations and review corrective actions to verify proper implementation, effectiveness, and maintenance of commitments at suppliers or internal sites. For internal sites, formulate recommendations for corrective actions.
Participate in strategic initiatives to improve compliance with regulatory requirements and standards.
Collaborate with R&D QA to coordinate and conduct joint audits.
Communicate and coordinate supplier audit activities with internal stakeholders such as procurement, SQA, EQA, manufacturing sites, and commercial affiliates, as well as external stakeholders.
Ensure audits are conducted according to the annual audit schedule.
Ensure no product launch delays or business interruptions due to supplier audit delays, thereby assuring supply to AbbVie patients.
Additional Information Qualifications
Bachelor's Degree in a technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 4 years) with exposure to pharmaceutical, medical device, biologics, and related industries. ASQ certification is preferred.
6+ years of relevant experience, including 4+ years in Quality Assurance with project management experience, and 2+ years in compliance/auditing.
Technical background with understanding of Quality Assurance audit processes and worldwide GMP regulations.
Knowledge of quality/operational systems supporting facility, product design, development, production, and distribution.
Excellent communication skills, interpersonal skills, tact, maturity, and sound judgment.
Ability to effectively communicate and influence internal and external stakeholders across various technical and functional areas.
AbbVie is an equal opportunity employer committed to integrity, innovation, and community service. Equal Opportunity Employer/Veterans/Disabled.
For more information, visit
here . Applicants seeking accommodations can find more information
here .
#J-18808-Ljbffr
Job Description Thank you for considering a future opportunity with our company! We are currently not hiring for this specific role, but we would love to connect with talented individuals interested in potential future positions. By joining our talent pipeline, you will be the first to be notified when suitable opportunities arise.
This requisition is for building a network of exceptional individuals with the skills and experience required for future openings. By submitting your application, you will be added to our talent pipeline and considered for upcoming opportunities.
Qualifications Purpose The function of Audit and Compliance Senior Auditor/Lead is to perform comprehensive audits for compliance with US and foreign regulation requirements, providing constructive evaluation of quality-related systems for AbbVie plants, affiliates, quality service areas, and/or suppliers. The role ensures activities are performed and documented in accordance with AbbVie policies/procedures and applicable quality and regulatory requirements, maintaining the quality, effectiveness, and safety of our products. This position requires a balance of involvement and objectivity.
Responsibilities
Assess compliance of systems, facilities, and procedures per applicable regulations, ensuring adherence to regulatory requirements and AbbVie specifications.
Provide feedback through audit observations and review corrective actions to verify proper implementation, effectiveness, and maintenance of commitments at suppliers or internal sites. For internal sites, formulate recommendations for corrective actions.
Participate in strategic initiatives to improve compliance with regulatory requirements and standards.
Collaborate with R&D QA to coordinate and conduct joint audits.
Communicate and coordinate supplier audit activities with internal stakeholders such as procurement, SQA, EQA, manufacturing sites, and commercial affiliates, as well as external stakeholders.
Ensure audits are conducted according to the annual audit schedule.
Ensure no product launch delays or business interruptions due to supplier audit delays, thereby assuring supply to AbbVie patients.
Additional Information Qualifications
Bachelor's Degree in a technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 4 years) with exposure to pharmaceutical, medical device, biologics, and related industries. ASQ certification is preferred.
6+ years of relevant experience, including 4+ years in Quality Assurance with project management experience, and 2+ years in compliance/auditing.
Technical background with understanding of Quality Assurance audit processes and worldwide GMP regulations.
Knowledge of quality/operational systems supporting facility, product design, development, production, and distribution.
Excellent communication skills, interpersonal skills, tact, maturity, and sound judgment.
Ability to effectively communicate and influence internal and external stakeholders across various technical and functional areas.
AbbVie is an equal opportunity employer committed to integrity, innovation, and community service. Equal Opportunity Employer/Veterans/Disabled.
For more information, visit
here . Applicants seeking accommodations can find more information
here .
#J-18808-Ljbffr