Describe the primary goals, objectives or functions or outputs of this position.
Primarily responsible for providing quality consultation, training, auditing and coordination of projects
necessary to maintain and improve the quality of work-related processes and new product
development programs worldwide.
Responsibilities:
Carry out job duties independently, including study-specific inspections, internal system / process based-audits, and external supplier CRO audits. Requires minimal supervision or direction.
Independently plan and conduct internal systems audits, external supplier CRO audits and due diligence assessments for merger/acquisition and in-licensing opportunities. Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues.
Gather internal audit metrics, perform trend analysis and present to management.
Provide guidance and training on GLP regulations and guidelines for auditors and functional area personnel.
Collaborate with and assist the Inspection Management group on preparation for and support of inspections by regulatory agencies.
Develop / maintain and update departmental systems, procedures and records pertinent to position responsibilities.
Elevate issues to management, as necessary, in meeting these responsibilities.
Lead goals with cross-functional or broader scope and resolve team issues with minimal oversight.
This is an experienced level quality assurance auditor position. This individual is expected to identify and resolve problems, have effective interpersonal skills, work independently, mentor QA auditors, and also be an effective cross-functional team lead.
Qualifications & Requirements Bachelor's degree, preferably in life sciences or engineering.
Must have demonstrated strong leadership competencies, broad technical capabilities, and independence.
6+ years’ experience in function or related fields, such as, toxicology, bioanalytical laboratory, analytical chemistry, clinical pathology, Quality Assurance and/or Regulatory Affairs.
In-depth knowledge of global GLP/GCP regulatory standards.
An equivalent combination of education and experience may be accepted
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 Tik Tok.
