Senior GCP Compliance Auditor

MN Climate Innovation Finance Authority (MNCIFA); North Chicago (IL); Remote; USD 80,000 - 120,000; Full time

Job summary

A leading company is seeking a Compliance Auditor responsible for conducting site audits to ensure compliance with regulations and company policies. The ideal candidate will possess a bachelor's degree in a relevant field and have several years of experience in the pharmaceutical industry. This position allows for remote work within the US, with some travel requirements, offering a comprehensive benefits package.

Benefits

Paid time off including holidays and sick leave

Medical, dental, and vision insurance

401(k) participation for eligible employees

Short-term and long-term incentive programs

Qualifications

• 5-7 years in pharmaceutical industry experience.
• 2 years of QA auditing experience preferred.
• Minimum 7 years of combined experience.

Responsibilities

• Conduct audits of clinical sites for compliance.
• Review clinical research documents and assess quality.
• Communicate audit results effectively.

Skills

Quality Assurance

Regulatory Affairs

Compliance Evaluation

Education

Bachelor's degree in physical or life science, nursing, pharmacy

Job description

ICompany 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 Tik Tok.

Job Description

Purpose:

Primarily responsible for conducting audits of investigative clinical sites in R&D to assess and assure compliance with regulations, guidelines, policies, procedures and sponsor requirements

Responsibilities:

• Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures.
• Lead investigation site audits to ensure compliance to global regulatory requirements as well as AbbVie requirements. Effectively communicate audit results, both orally and in writing. Review corrective action plans/audit responses for adequacy and approve if adequate
• Lead Global System Audits to evaluate internal Abbvie areas for compliance to applicable SOPs and local regulations
• Review clinical research documents, such as research reports, to assess the quality and compliance to policies, procedures, and applicable governmental regulations
• Assist in periodic audits to evaluate vendor R&D facilities, equipment, personnel, methods, practices, computer systems, procedures, records and controls for compliance to protocols, policies, SOPs, and applicable governmental regulations globally
• Evaluate the potential risk of compliance deficiencies
• Review policies and procedures and suggest improvements
• Maintain effective communication of project related information
• Provide training and consulting services to the organization to ensure GCP compliance
• Assist with Clinical QA program management activities in support of studies and projects to ensure compliance with regulations, guidelines, policies, procedures and sponsor requirements

This role can be remote within the US with about 30% travel expectations.

Qualifications

• Bachelor's degree in a physical science, life science, nursing, pharmacy or equivalent experience required
• 5-7 years of pharmaceutical industry experience in Quality Assurance I Regulatory Affairs
• 5-7 years of clinical research and development
• Minimum 2 years of QA auditing experience (GCP Auditing preferred)
• Minimum of 7 years total combined experience required (not necessarily the sum of the above)

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.
• This job is eligible to participate in our long-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 Company's sole and absolute discretion unless and until paid and may be modified at the Company's 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 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.htmlI