Senior GCP Compliance Auditor (all genders) (permanent / full-time)

Company 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 . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

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 to address some of tomorrow\’s 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 for developing and increasing your own skills? You’ve come to the right place!

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

Responsibilities

1. Interpret, explain, and apply the applicable current regulations, guidelines, policies, and procedures.
2. Familiarity with global electronic records/electronic signature and data integrity requirements preferred.
3. 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.
4. Lead or participate in investigator site audits to ensure compliance with global regulatory requirements as well as AbbVie requirements.
5. Lead Global System and Supplier Audits to evaluate internal AbbVie areas for compliance with applicable SOPs and local regulations.
6. Effectively communicate audit results, both orally and in writing.
7. Review corrective action plans/audit responses for adequacy and approve if adequate.
8. Evaluate the potential risk of compliance deficiencies.
9. Review policies and procedures and suggest improvements.
10. Maintain effective communication of project-related information.
11. Provide training and consulting services to the organization to ensure GCP compliance.
12. Escalate potential quality issues to management.
13. 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

1. 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.
2. Degree in a physical science, life science, nursing, pharmacy, or equivalent experience required.
3. 5-7 years of pharmaceutical industry experience in Quality Assurance / Regulatory Affairs.
4. 5-7 years of clinical research and development experience.
5. Minimum 2 years of QA auditing experience (GCP Auditing preferred).
6. Ability to work independently as well as a team member.

Here\’s how we can move mountains together

1. with a diverse work environment where you can have a real impact.
2. with an open corporate culture.
3. with an attractive salary.
4. with an intensive onboarding process with a mentor at your side.
5. with flexible work models for a healthy work-life balance.
6. with corporate health management that offers comprehensive health and exercise programs.
7. with company social benefits.
8. with a wide range of career opportunities in an international organization.
9. with top-tier, attractive development opportunities.
10. 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.

At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us, and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you in person.

Any questions? Feel free to email us at – we look forward to hearing from you!

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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