Senior GLP Auditor Specialist

North Chicago, IL - USA

Monthly Salary: Not Disclosed

Posted on: 10 hours ago

Vacancies: 1 Vacancy

Job Summary

Purpose:

Describe the primary goals objectives or functions or outputs of this position.
Primarily responsible for providing quality consultation training auditing and coordination of projects
necessary to maintain and improve the quality of work-related processes and new product
development programs worldwide.

Responsibilities:

Carry out job duties independently including study-specific inspections internal system / process based-audits and external supplier CRO audits. Requires minimal supervision or direction.
Independently plan and conduct internal systems audits external supplier CRO audits and due diligence assessments for merger/acquisition and in-licensing opportunities. Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues.
Gather internal audit metrics perform trend analysis and present to management.
Provide guidance and training on GLP regulations and guidelines for auditors and functional area personnel.
Collaborate with and assist the Inspection Management group on preparation for and support of inspections by regulatory agencies.
Develop / maintain and update departmental systems procedures and records pertinent to position responsibilities.
Elevate issues to management as necessary in meeting these responsibilities.
Lead goals with cross-functional or broader scope and resolve team issues with minimal oversight.
This is an experienced level quality assurance auditor position. This individual is expected to identify and resolve problems have effective interpersonal skills work independently mentor QA auditors and also be an effective cross-functional team lead.

Qualifications :

Bachelors degree preferably in life sciences or engineering.
Must have demonstrated strong leadership competencies broad technical capabilities and independence.
6 years experience in function or related fields such as toxicology bioanalytical laboratory analytical chemistry clinical pathology Quality Assurance and/or Regulatory Affairs.
In-depth knowledge of global GLP/GCP regulatory standards.
An equivalent combination of education and experience may be accepted

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 role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors 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 is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Employment Type :

Full-time

Purpose:Describe the primary goals objectives or functions or outputs of this position.Primarily responsible for providing quality consultation training auditing and coordination of projectsnecessary to maintain and improve the quality of work-related processes and new productdevelopment programs wo...

Purpose:

Responsibilities:

Carry out job duties independently including study-specific inspections internal system / process based-audits and external supplier CRO audits. Requires minimal supervision or direction.
Independently plan and conduct internal systems audits external supplier CRO audits and due diligence assessments for merger/acquisition and in-licensing opportunities. Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues.
Gather internal audit metrics perform trend analysis and present to management.
Provide guidance and training on GLP regulations and guidelines for auditors and functional area personnel.
Collaborate with and assist the Inspection Management group on preparation for and support of inspections by regulatory agencies.
Develop / maintain and update departmental systems procedures and records pertinent to position responsibilities.
Elevate issues to management as necessary in meeting these responsibilities.
Lead goals with cross-functional or broader scope and resolve team issues with minimal oversight.
This is an experienced level quality assurance auditor position. This individual is expected to identify and resolve problems have effective interpersonal skills work independently mentor QA auditors and also be an effective cross-functional team lead.

Qualifications :

Bachelors degree preferably in life sciences or engineering.
Must have demonstrated strong leadership competencies broad technical capabilities and independence.
6 years experience in function or related fields such as toxicology bioanalytical laboratory analytical chemistry clinical pathology Quality Assurance and/or Regulatory Affairs.
In-depth knowledge of global GLP/GCP regulatory standards.
An equivalent combination of education and experience may be accepted

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 role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors 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.

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

Work :

Employment Type :

Full-time

Key Skills

Auditing
Accounting Software
Data Analytics
GAAP
Accounting
Analysis Skills
SOX
Financial Analysis
Financial Report Interpretation
Internal Audits
Mentoring
GAAS

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About Company

AbbVie

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more

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