Senior GCP Compliance Auditor

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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Key Responsibilities

• Responsible for ensuring high quality clinical trials are performed in compliance with worldwide regulatory expectations.

• Demonstrate good scientific rationale and interpretation of data integrity through regulatory submissions.

• Responsible for preparing, conducting, and reporting audit activities of clinical trials activities utilizing software such as TrackWise, Salesforce, IMPACT, Veeva Vault, Spotfire, Medidata, InForm, YPrime, Endpoint, Premier, Calyx, CRF Health, etc.

• Responsible for leading investigator site audits to ensure compliance with global regulatory requirements.

• Lead internal audits to assess the systems processed and procedures in place to support the clinical trial conduct and their overall compliance with ICH GCP guidelines, applicable regulations, and the organization's Quality System.

• Appropriate protection of all human subjects participating in organizational Clinical Trials.

• Assist with Clinical QA program management activities in support of studies and projects to ensure compliance with regulations, guidelines, policies, procedures and sponsor requirements.

• Deliver consistent, high-quality documents and clinical program activities for Research and Development (R&D).

• Ensure that R&D remains in compliance with worldwide regulatory expectations and requirements.

• Lead and develop strategy for global Quality Assurance in alignment with R&D strategies.

• Interpret, explain and