Senior Compliance Auditor

3 weeks ago

North Chicago, United States AbbVie, Inc Full time

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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Purpose

The Senior Audit and Compliance Auditor provides leadership, direction and perform evaluations for compliance with US and foreign regulation requirements and provide relevant and constructive evaluation of quality related systems for AbbVie plants, affiliates, functional areas and suppliers that provide materials, services and products to AbbVie. This includes API suppliers, contract labs, excipient suppliers, commodity suppliers and third party manufacturers. Is also responsible for providing support to AbbVie plants in the resolution of regulatory issues and issues related to suppliers. Their leadership, direction and execution in the area of GMP compliance and quality assures that activities are performed and documented in accordance with AbbVie policies/procedures and applicable quality and regulatory requirements to assure the quality, effectiveness and safety of our products.

Responsibilities

* 75% Travel
* Assess compliance of systems, facilities, and procedures per applicable regulations through audits and assessments, assuring compliance to regulatory requirements and AbbVie specifications.
* Provide feedback in the form of audit observations, formulate recommendations, and review corrective actions to determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained.
* The major responsibilities of this position are primarily focused on AbbVie facilities and key suppliers whose processes are more complex, comprehensive and critical to the business.
* Lead or participating in more technically complex and strategic projects.
* The position serves a tactical purpose for AbbVie and must achieve a difficult balance of involvement, independence and objectivity.
* Lead or participate in strategic initiatives to improve compliance to regulatory requirements and standards.
* Collaborate with internal operations on quality issues at AbbVie facilities or those related to suppliers and in the resolution of supplier exceptions to AbbVie specifications. Auditing serves to provide feedback in the form of audit observations, formulation of recommendations, review of corrective actions and to determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained.
* The position also provides an active role within the corporation as experts in GMP requirements. The strategic focus is for early detection and prevention, followed by correction of issues.

Qualifications

Qualifications

* Bachelor's Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 8 years) with sufficient exposure to pharmaceutical, medical device, or combination product related industries.
* Must have a technical background and requires a thorough understanding of the audit process and an extensive knowledge of worldwide requirements related to GMP regulations for quality systems and compliance.
* Must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support and service and understand the principles of quality management.
* The individual must have excellent oral/written communications skills. Personal skills needed include interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self-reliance, organizational/administrative skills and sound judgment.
* Persuasive, effective communication skills are essential with an ability to work effectively outside of the company and across divisional and technical areas.
* 6+ years in Quality Assurance with some management experience preferred and three more years in another function in the pharmaceutical, medical device/nutritional or related industry. Four years in compliance/auditing or regulatory affairs is desirable. Total combined experience expected to be at least 10 years.
* ASQ certification desired.

Additional Information

Applicable only to applicants

  • Senior Auditor, Compliance

    1 month ago

    North Chicago, United States AbbVie, Inc Full time

    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...

  • Senior Auditor, Compliance

    1 week ago

    North Chicago, United States AbbVie, Inc Full time

    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...

  • Senior Auditor, Compliance

    3 weeks ago

    North Chicago, United States tapwage Full time

    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...

  • Senior Auditor Compliance

    1 week ago

    North Chicago, United States AbbVie Full time

    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...

  • Senior Auditor Compliance

    3 weeks ago

    North Chicago, United States AbbVie Full time

    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...

  • Senior Auditor, Compliance

    3 weeks ago

    North Chicago, United States AbbVie Full time

    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...

  • Senior Auditor, Compliance

    3 weeks ago

    North Chicago, United States AbbVie Full time

    Company DescriptionAbbVie'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...

  • Senior Auditor, Compliance

    1 week ago

    North Chicago, United States AbbVie Full time

    Company DescriptionAbbVie'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...

  • Senior Compliance Auditor

    2 weeks ago

    North Chicago, United States AbbVie Full time

    Job Description Purpose The Senior Audit and Compliance Auditor provides leadership, direction and perform evaluations for compliance with US and foreign regulation requirements and provide relevant and constructive evaluation of quality related systems for AbbVie plants, affiliates, functional areas and suppliers that provide materials, services and...

  • Senior Auditor, Compliance

    3 weeks ago

    North Chicago, United States AbbVie Full time

    Job DescriptionJob DescriptionCompany DescriptionAbbVie'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...

  • Senior Auditor, Compliance

    2 weeks ago

    North Chicago, United States AbbVie Full time

    Job DescriptionJob DescriptionCompany DescriptionAbbVie'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...

  • Senior Auditor, Compliance

    1 week ago

    North Chicago, United States AbbVie Full time

    Job DescriptionJob DescriptionCompany DescriptionAbbVie'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...

  • Senior Auditor, Billing Compliance

    3 weeks ago

    Chicago, United States Edward-Elmhurst Health Full time

    Senior Auditor, Billing Compliance page is loaded Senior Auditor, Billing Compliance Apply locations NSO 1301 Central St Corporate Office Evanston EDO Warrenville 3S 517 Winfield Road time type Full time posted on Posted 3 Days Ago job requisition id R9720 Senior Auditor, Billing Compliance Position Highlights: Position: Senior Auditor, Billing Compliance...

  • Senior Global Compliance Auditor

    2 weeks ago

    Chicago, United States Stealth Recruiting Services Full time

    Job DescriptionJob Description95k to 110k Job DescriptionThe Senior Compliance Auditor has the primary responsibility to conduct global sales and marketing compliance audits for the US operating divisions and international affiliates.Scope may include but not limited to compliance audits in the following broadly described areas:Research FundingNo-Charge...

  • Senior Global Compliance Auditor

    2 months ago

    Chicago, United States Stealth Recruiting Services Full time

    Job DescriptionJob Description95k to 110k Job DescriptionThe Senior Compliance Auditor has the primary responsibility to conduct global sales and marketing compliance audits for the US operating divisions and international affiliates.Scope may include but not limited to compliance audits in the following broadly described areas:Research FundingNo-Charge...

  • Senior Global Compliance Auditor

    7 days ago

    Chicago, United States Stealth Recruiting Services Full time

    Job DescriptionJob Description95k to 110k Job DescriptionThe Senior Compliance Auditor has the primary responsibility to conduct global sales and marketing compliance audits for the US operating divisions and international affiliates.Scope may include but not limited to compliance audits in the following broadly described areas:Research FundingNo-Charge...

  • Senior Compliance Auditor

    2 weeks ago

    North Chicago, United States AbbVie Full time

    Job DescriptionJob DescriptionCompany DescriptionAbbVie'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...

  • Senior Compliance Auditor

    7 days ago

    North Chicago, United States AbbVie Full time

    Company DescriptionAbbVie'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...

  • Senior Compliance Auditor

    1 week ago

    North Chicago, United States AbbVie Full time

    Job DescriptionJob DescriptionCompany DescriptionAbbVie'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...

  • Compliance Senior Auditor

    3 weeks ago

    Chicago, United States Sevita Full time

    At Sevita we believe that everyone deserves to live well. For more than 50 years, our team members have provided home and community-based health care for adults, children and their families across the United States. As a member of our corporate team, you'll help shape the work that supports how our business runs, the services we provide, and the...