Principal Associate-Quality Auditor–GQA

The Quality Auditor is part of the Global Quality Auditing (GQA) 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 Global Quality 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.

Responsibilities

Scheduling, preparing, conducting, and reporting GQA audits and assessments of GCP operations, both internally and externally (contracted); Participate in or lead the risk assessment of GCP operations in support of generating the GQA risk-based annual audit plan; Appropriately escalate any compliance issues; Meet the requirements outlined in quality standards, quality manuals, policies, procedures, and tools; Participate in or lead the preparation and/or review of standards, policies, procedures, and guidelines used to establish quality requirements; Participate in or lead the preparation of organizational metrics and trending of audit findings; Provide audit-related advice to GCP operations on the interpretation of corporate and regulatory GCP requirements; Maintain good interpersonal and communication skills with auditees and business areas; Complete required training for the roles identified in the Individual Training Plan (ITP); Be continually aware of current industry trends and regulatory agency interpretation of GCP requirements; Seek self-development in GCP areas and share knowledge with other members of the group or company; Participate or lead divisional improvement efforts, including Six Sigma projects and departmental teams; Support training and qualification of other auditors

Requirements

Bachelor's Degree (or equivalent work experience) in physical or biological sciences, or other relevant technical area; Relevant experience (minimum of 5 years) within the GCP area at Lilly or within the pharmaceutical environment; Experience working with third party organizations; Ability to understand detailed scientific information, while remaining anchored in the "Big Picture"; Ability to interpret and apply regulations, regulatory guidance, codes, and public expectations and identify and recommend compliance changes as appropriate; Excellent interpersonal skills, ability to remain constructive and civil in difficult situations; 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; Strong communication skills in English (speaking, writing); Must be able to travel up to 40% (duration 1-2 weeks), sometimes on short notice; Work under pressure on multiple tasks concurrently and meet deadlines in a fast-paced work environment; Proven ability to think and analyze from a process perspective; Project management skills; Process information to identify linkages and trends; Work independently as well as collaboratively within a global team environment; 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

Nice to have

Business communication skills in Japanese (speaking, writing)