Sr. Principal Associate-GQAAC
US: USA Remote, United States
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $162,800At Lilly, we serve an extraordinary purpose. We make a difference for people around the global by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Brand Description:
The Quality Auditor is part of the Global Quality Auditing and Compliance (GQAAC) division and provides quality assurance through the execution of internal and external audits in support of pharmaceutical development, non-clinical and clinical research, product commercialization, pharmacovigilance and consumer information quality (CIQ) for Lilly. Through auditing, the Quality Auditor assures that GXP operations conducted and sponsored by Lilly are performed in accordance with company standards, policies, procedures and practices and are compliant with current regulatory requirements and expectations and applicable guidelines and industry standards.
GQAAC has adopted a proactive approach to ensure the effective implementation of a continuous quality assurance program. This program has the objectives of guaranteeing compliance with regulations in all geographies where Lilly operates and of further enhancing the quality of operations of Lilly and their contracted parties. The Quality Auditor is an expert quality professional, acting as a key contributor to the development and execution of the GQAAC audit program within the GXP area(s) of responsibility.
Key Objectives/Deliverables:
The following activities will be performed according to current GQAAC
procedures, guidelines and tools. These responsibilities are not intended to be
all-inclusive:
Auditing
- Scheduling, preparing, conducting and reporting Global Quality audits and assessments of research and commercial operations, both internally and externally (contracted) to assess the level of compliance with company standards, policies, practices and procedures and current regulations and guidelines. This includes leadership of audit …
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Flexible benefits Philanthropy and volunteerism Vacation Vacation benefits Volunteerism
Tasks- Assess compliance
- Conduct audits
- Lead audit teams
- Participate in risk assessments
- Prepare reports
Analytical Auditing Audits Clinical Research Commercialization Communication Communications Compliance Decision making Execution GCP Healthcare Influence Interpersonal Leadership Manufacturing Organization Organizational Pharma Pharmaceutical Development Philanthropy Problem-solving Quality Assurance Regulatory Compliance Reporting Research Risk Assessment Supervision Training Volunteerism Writing
Experience5 years
Education TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9