Clinical Quality Auditor Job in Indianapolis 46225, Indiana Us
For more than 130 years, Eli Lilly and Company has been dedicated to meeting the health care needs of people in the United States and around the world. We address these needs primarily by developing innovative medicines—investing a higher percentage of our sales in research and development than any other major pharmaceutical company. If you are interested in being considered for employment with a “Best in Class” Pharmaceutical company, please review the following opportunity:
Clinical Quality Auditor
The Clinical Quality Auditor is part of the Global Quality Auditing and Compliance (GQAAC) division and represents the quality auditing interface supporting clinical research operations. Through auditing, the Clinical Quality Auditor assures that global clinical research operations conducted and sponsored by the Company are performed in accordance with company standards, policies, practices and procedures and are compliant with current regulations and guidelines. This position involves the auditing of clinical research operations, both internally and externally (e.g, investigator sites and CRO's). GQAAC is operating as a valued business partner and taking a proactive approach to further enhancing the quality status of business operations and regulatory compliance. The Clinical Quality Auditor plays a key part in contributing to the implementation of this strategic approach to quality auditing oversight. The following activities will be performed according to current GQAAC procedures, guidelines and tools. These responsibilities are not intended to be all-inclusive:
KEY OBJECTIVES/DELIVERABLES:
- Auditing:
- Scheduling, preparing, conducting and reporting GQAAC audits and assessments of research operations, both internally and externally (contracted) to assess the level of compliance with company standards, policies, practices and procedures and current regulations and guidelines.
- Participate or lead in the risk assessment of research operations in support of generating the GQAAC risk-based annual audit plan.
- Appropriately escalate any compliance issues.
- Meet the requirements outlined in quality standards, quality manuals, policies, procedures, and tools.
- This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.
MINIMUM REQUIREMENTS:
- Bachelors Degree
- Minimum of 3 years conducting or auditing clinical studies within the pharmaceutical environment.
- Ability to interpret and apply regulations, regulatory guidance, codes and public expectations and identify and recommend compliance changes as appropriate.
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
ADDITIONAL SKILLS/PREFERENCES:
- Excellent interpersonal skills, ability to remain constructive and civil in difficult situations.
- Certified GCP auditor/quality assurance professional.
- Experience working with Third Party Organizations (investigator sites, clinical research organizations).
- Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization.
- Experience working on a global team and sharing knowledge.
- Experience with computers and entering data into databases.
- Good analytical/problem-solving skills.
- Work under pressure on multiple tasks concurrently and meet deadlines in a fast-paced work environment with frequent interruptions and changing priorities.
- The ability to understand detailed scientific information, while remaining anchored in the Big Picture.
- Proven ability to think and analyze from a process perspective.
- Project management skills.
- Process information to identify linkages and trends and apply findings to compliance strategies as well as to individual assignments.
- Work independently as well as collaboratively within a global team environment.
- Deliver constructive feedback to customers while providing a high level of customer service.
- Ability to influence and manage change/conflict.
- Establish and maintain effective working relationships at all levels internal and external to Lilly.
- Ability to think on your feet and be pragmatic in decision making
OTHER CONSIDERATIONS:
- Domestic and international travel is required to fulfill these job responsibilities.
- Must be able to travel up to 40% (duration 1-2 weeks), sometimes on short notice.
- This position is based in Indianapolis and will require the candidate to relocate to the Indianapolis area.
Do you find this job interesting? Here are similar opportunities for your review.
Lilly credits its exceptional employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. A company rich in heritage, Lilly employs individuals, conducts research and markets products worldwide. By providing for the unmet needs of our customers through a continuous stream of innovation, we will outgrow all competitors.
Lilly earns consistent and wide recognition for creating an exceptional work environment:
- Business Week magazine 50 Best Places To Launch A Career™
- FORTUNE America’s Most Admired Companies™
- FORTUNE 50 Best Companies for Minorities™
- Working Mother 100 Best Companies for Working Mothers™
- Industry Week magazine 100 Best-Managed Companies™
- Business Ethics magazine 100 Best Corporate Citizens™
- Science magazine Best Companies for Scientists™
ELI LILLY AND COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER