Senior Auditor - RDQA Clinical Quality Audit (all genders) (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 www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and TikTok.

Job Description

People. Passion. Possibilities. Three words that make a world of difference.

More than a job. It's a chance to make a real difference.

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 healthcare? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities to develop and enhance your skills? You've come to the right place!

Position: Senior Auditor - RDQA Clinical Quality Audit (all genders) (full-time)

In this role, you are primarily responsible for executing the Clinical audit program, including scheduling, planning, reporting, and resolution of Clinical audits. You will ensure alignment with RDQA policies and procedures and take the lead in developing and implementing the Clinical Audit quality system. Recognized as a Subject Matter Expert, you will provide support on GCP and quality topics and advise business partners to ensure compliance with worldwide requirements and expectations.

• Based in UK, Germany, Italy, France, or Spain

Key Responsibilities:

• Ensure quality and compliance in a regulated environment, including worldwide regulations, country-specific standards, and AbbVie's policies through audit and QA oversight activities.
• Lead the Clinical audit program by planning and executing all types of audits and working with auditees to resolve non-compliance issues. Take the lead on complex audits.
• Manage risk-based assessments to identify potential audits.
• Enhance the AbbVie Quality System by developing and implementing systems and processes to support global quality assurance.
• Contribute to continuous improvement initiatives to ensure compliance with regulations and policies.
• Act as Audit Lead/SME for assigned audit types, maintaining standards, tools, templates, and guidance documents, and onboarding new auditors.
• Mentor Clinical Audit staff and support GCP inspections as needed.
• Provide support and consultation on Clinical Quality and GCP regulations to RDQA and business partners.

Qualifications:

• Bachelor’s degree in science, healthcare profession, or equivalent experience.
• 3-5 years in the biopharmaceutical industry or with a regulatory authority, with experience in Quality Assurance and Clinical Research Development.
• 3-5 years in Clinical Quality Auditing.
• Strong understanding of clinical trial regulations (e.g., ICH-GCP, EU Clinical Trial Directive/Regulation).
• Analytical skills with the ability to interpret data.
• Ability to work independently and promote a dynamic environment.
• Flexibility to adapt and prioritize effectively.
• Good project management, interpersonal, and communication skills.
• Willingness to travel internationally.
• Proficiency in English (oral and written).

What we offer:

• A diverse work environment with impactful opportunities.
• An open corporate culture.
• Attractive salary and comprehensive onboarding with mentorship.
• Flexible work models supporting work-life balance.
• Health and exercise programs, social benefits, and career development opportunities.
• A recognized 'Great Place to Work' organization committed to diversity, equity, inclusion, and community engagement.

At AbbVie, your contributions matter. Join us to grow, succeed, and make a difference. We look forward to your complete CV and discussing your future with us.

Questions? Contact us at TalentAcquisition.de@abbvie.com.

Additional Information

AbbVie is an equal opportunity employer committed to integrity, innovation, and community service. For US & Puerto Rico applicants, more info at https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html. For accommodations, visit https://www.abbvie.com/join-us/reasonable-accommodations.html.