Sr. Principal Associate - Global Quality Auditing and Compliance

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.

The quality auditor is part of the Lilly Global Quality Auditing and Compliance (GQAAC) organization and assures quality assurance through the execution of internal and external audits in support of pharmaceutical development and commercialization for Lilly. Through auditing, the GQAAC auditor assures that GxP operations conducted or sponsored by Lilly are performed in accordance with company standards, policies, procedures, and practices and are compliant with current regulatory requirements and expectations, applicable guidelines, and industry standards.

GQAAC operates as a valued business partner by taking a proactive approach to further enhancing the quality status of business operations and regulatory compliance. The 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:

• Interpret and apply Lilly standards, regulations, regulatory guidance, industry standards, to identify compliance risks and maintain a comprehensive knowledge of applicable regulations, technical knowledge, and training to meet the auditing responsibilities.
• Lead or participate in planning, scheduling, preparing, conducting, appropriately escalating compliance issues, and reporting audits, assessments, and due diligences of GMP operations to assess the level of compliance with established standards and current regulations and guidelines.
• Lead or participate in risk assessments and mock regulatory inspections of GMP operations to assess level of compliance and/or readiness to meet established standards and current regulations and guidelines, as applicable.
• Provide technical input and recommendations to audit observation reports during the Audit Review Board meeting, as applicable.
• Exhibit ethical behavior when auditing, including integrity, objectivity, and confidentiality, including the competency to recluse oneself from an audit when a conflict of interest or lack of competency in a specific area exists.
• Exhibit interpersonal skills that are relevant to auditing, such as listening, questioning, being tactful and having appropriate non-verbal skills, handling conflict in a constructive manner and communicating (both written and verbal) in a clear and concise manner. Exhibit skills relevant to auditing, such as evaluating and judging, drawing conclusions, understanding technical material and data integrity concepts, business understanding, identifying problem areas, knowledge of audit principles, and ability to manage time.

• Lead or participate in the continuous improvement of the GQAAC quality system and other GQAAC organizational priorities.
• Participate in the continuous improvement of the global quality system and other corporate priorities, as requested.
• Establish and maintain relationships with the relevant business units, including providing audit-related advice, interpretation of Lilly global quality standards and regulations, and inspection readiness assistance.
• Participate and/or support GQAAC self-assessments or regulatory inspections.

• Complete required training and qualifications as identified in your Learning Plan.
• Remain current of regulatory and industry trends, including regulatory agency interpretation of requirements.
• Serve as a mentor and coach for others within the GQAAC organization.
• Attending training courses, conferences, or association meetings to continue to gain knowledge and to share such information with other members of the group or company to increase their awareness, as assigned.

• Minimum of five (5) years' experience related to the pharmaceutical industry.

• Ability to work safely to ensure self-safety and the safety of others.
• Strong working knowledge of global regulations and guidelines (e.g., FDA, EU, and industry standards (e.g., ICH, ISPE, PIC/s) for GMP operations) and the ability to interpret and apply regulatory and guidelines to the pharmaceutical industry.
• Prior auditing experience, including auditor certification by an external body (e.g., ASQ Quality Auditing).
• Capacity to produce high quality results across multiple projects and demands, through effective prioritization, while…