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Senior GCP Compliance Auditor
vor 4 Wochen
About the Role:
We are seeking a highly skilled Senior GCP Compliance Auditor to join our team at AbbVie. As a Senior GCP Compliance Auditor, you will be responsible for ensuring that our company's products and services meet the highest standards of quality and compliance.
Key Responsibilities:
* Interpret and apply relevant regulations, guidelines, and policies to ensure compliance
* Plan, organize, and lead 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 regulations globally
* Lead or participate in investigator site audits to ensure compliance to global regulatory requirements as well as AbbVie requirements
* Lead Global System and Supplier Audits to evaluate internal Abbvie areas for compliance to applicable SOPs and local regulations
* Effectively communicate audit results, both orally and in writing
* Review corrective action plans/audit responses for adequacy and approve if adequate
* 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
* Escalate potential quality issues to management
Requirements:
* Bachelor's Degree or equivalent education and typically 12 years of experience, Master's Degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience
* 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)
* Ability to work independently as well as a team member
About AbbVie:
At AbbVie, we are committed to creating a diverse and inclusive work environment that allows our employees to thrive. We believe that our employees are our greatest asset and are dedicated to providing them with the resources and support they need to succeed. We are proud to be a Great Place to Work and are committed to making a positive impact on the environment and our communities.
What We Offer:
* A diverse and inclusive work environment
* Opportunities for career growth and development
* Competitive salary and benefits package
* Flexible work models for a healthy work-life balance
* Comprehensive health and exercise programs
* Company social benefits
* A wide range of career opportunities in an international organization
* Top-tier, attractive development opportunities
* A strong international network
How to Apply:
If you are a motivated and experienced professional looking for a new challenge, please submit your application, including your complete CV, to us. We look forward to hearing from you.
