Senior GCP Compliance Auditor
Senior GCP Compliance Auditor
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Not Disclosed
Salary Not Disclosed
1 Vacancy
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 :
- Bachelors 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 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:
Yes
Employment Type :
Full-time
Employment Type
Remote
