Sr. Advisor, GQA

Eli Lilly and Company • Us, IN

7d

About The Position

The Senior Advisor is part of Lilly’s Global Quality Auditing (GQA) division and provides quality assurance by executing internal and external audits and assessments in support of pharmaceutical development, non-clinical and clinical research, business development, product commercialization, and pharmacovigilance. Through auditing and technical expertise, the role helps ensure GxP operations conducted or sponsored by Lilly—or included in business development projects—comply with company standards, policies, procedures, current regulatory requirements, applicable guidelines, and industry standards. The Senior Advisor contributes to GQA’s technical strategy and its proactive approach to quality auditing oversight, risk management, and regulatory compliance.

The role plans and leads complex audits and assessments, assesses GxP risks and metrics, escalates compliance issues, and advises business areas on quality and data integrity. It also contributes to quality standards and procedures, audit metrics and trend analysis, regulatory inspection support, and quality education. The Senior Advisor builds relationships with business areas and regulatory authorities, provides technical mentorship and training, and supports divisional improvement efforts. Domestic and international travel is required, with travel up to 40% for periods of one to two weeks, sometimes on short notice.

Requirements

• Bachelor’s degree in physical or biological sciences, engineering, or a related scientific or technical discipline.
• At least 10 years of pharmaceutical industry experience working in a GCP or GLP area.
• At least 5 years of experience working with third-party organizations, such as CROs, clinical vendors or service providers, pre-clinical or clinical laboratories, clinics, and clinical supply organizations.
• At least 5 years of experience reviewing, assessing, or auditing pre-clinical or clinical data and reports.
• Maintain interpersonal and communication skills, with particular emphasis on verbal communication and technical writing.
• Ability to work under pressure on multiple concurrent tasks, meet deadlines, and adapt to interruptions and changing priorities.
• Ability to analyze processes, manage projects, identify information linkages and trends, and apply findings to compliance strategies and assignments.
• Ability to work independently and collaboratively in a global team environment and share knowledge.
• Ability to provide constructive feedback and a high level of customer service.
• Ability to influence and manage change and conflict, and maintain effective working relationships at all organizational levels, internally and externally.
• Pragmatic decision-making and the ability to think on one’s feet.
• Ability to interpret and apply regulations, regulatory guidance, codes, and public expectations, and recommend compliance changes.
• Ability to remain constructive and civil in difficult situations and communicate professionally and clearly, orally and in writing, to all organizational levels.
• Computer experience, including entering data into databases.
• Good analytical and problem-solving skills.
• Ability and willingness to travel domestically and internationally up to 40%, sometimes on short notice, for trips lasting one to two weeks.

Nice To Haves

• ASQ Certified Quality Auditor (CQA).

Responsibilities

• Perform audits and assessments to identify risks and provide technical input, mitigations, and recommendations concerning escalations and instances of non-compliance.
• Review GxP metrics for risk areas and propose appropriate audit mitigation strategies.
• Support implementation of GQA management and lead-team technical strategies and improvements.
• Participate in GQA lead-team meetings as needed to provide technical guidance and consultation.
• Plan and lead complex audits and assessments, including scheduling, preparation, conduct, and reporting for business development projects, research operations, and data integrity, internally and at external organizations.
• Assess compliance with company standards, policies, practices, procedures, regulations, and guidelines.
• Escalate risks and compliance issues appropriately.
• Participate in, prepare, conduct, and report cross-functional audits across multiple GxP or business areas.
• Educate business areas and leadership about quality and data integrity issues and influence robust corrective and preventive actions.
• Participate in or lead the preparation and review of quality standards, policies, procedures, and guidelines.
• Participate in or lead the preparation of organizational metrics and trending of audit findings.
• Advise research operations on interpreting corporate and regulatory GxP requirements related to quality management.
• Establish and maintain relationships with relevant business areas and regulatory authorities, including facilitating regulatory inspections when required.
• Provide technical expertise in developing and delivering quality and compliance education.
• Participate in external activities that build influence in areas relevant to the business.
• Provide technical mentorship and training to people within and outside the organization.
• Complete required training identified in the Individual Training Plan and stay current with industry trends and regulatory interpretations of GxP requirements.
• Attend training courses, conferences, or association meetings to build and share knowledge of GxP requirements.
• Mentor others in implementing GxP requirements.
• Participate in or lead divisional improvement efforts, including Six Sigma projects and departmental teams.
• Travel domestically and internationally, up to 40% for periods of one to two weeks, sometimes on short notice.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, such as healthcare and dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior