Senior Gcp Compliance Auditor

vor 4 Wochen

Ludwigshafen am Rhein, Deutschland AbbVie Vollzeit

**Company Description**
**Job Description** The job that makes possibilities real in patients' lives. And yours.**

**The job that helps you get ahead in life. Moving mountains together.**

Welcome to AbbVie As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place

Moving mountains together - as** Senior GCP Compliance Auditor (all genders) (permanent / full-time)**

**Responsibilities**
- Familiarity with global electronic records/electronic signature and data integrity requirements preferred
- 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
- Consistently demonstrate AbbVie’s Ways of Working and Leadership Attributes including a collaborative mindset and leadership. Create a learning environment, embrace the ideas of others, and manage innovation to reality

**Qualifications**
- 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

**Here's how we can move mountains together**
- with a diverse work environment where you can have a real impact
- with an open corporate culture
- with an attractive salary
- with an intensive onboarding process with a mentor at your side
- with flexible work models for a healthy work-life balance
- with a corporate health management that offers comprehensive health and exercise programs
- with company social benefits
- with a wide range of career opportunities in an international organization
- with top-tier, attractive development opportunities
- with a strong international network

Multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) - a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.

**Additional Information**

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

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