Sr. Advisor, GQA

Lilly • Indianapolis, IN

4d • $129,000 - $211,200

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. The work supports pharmaceutical development, non-clinical and clinical research, business development, product commercialization, and pharmacovigilance. Through auditing and technical expertise, the Senior Advisor helps ensure that GxP operations conducted or sponsored by Lilly, or associated with business development projects, comply with company standards, policies, procedures, current regulatory requirements and expectations, applicable guidelines, and industry standards.

The role contributes to GQA’s proactive quality-auditing approach and technical strategy. It involves planning and leading complex audits, identifying and escalating compliance risks, reviewing GxP metrics, advising business areas on quality and regulatory requirements, and supporting robust corrective and preventative actions. The Senior Advisor also contributes to quality standards and metrics, builds relationships with business areas and regulatory authorities, supports regulatory inspections, and provides quality and compliance education.

The position includes technical mentorship and training, participation in external professional activities and divisional improvement efforts, and ongoing development of knowledge of GxP requirements and regulatory trends. Domestic and international travel is required, up to 40% of the time, typically for durations of one to two weeks and 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 GLP laboratories, clinics, and clinical supply organizations.
• At least 5 years of experience reviewing, assessing, or auditing pre-clinical or clinical data and reports.
• Ability to manage multiple tasks under pressure, meet deadlines in a fast-paced environment, and adapt to interruptions and changing priorities.
• Ability to think and analyze from a process perspective; project management skills.
• Ability to identify linkages and trends in information and apply findings to compliance strategies and individual assignments.
• Ability to work independently and collaboratively in a global team.
• Ability to provide constructive feedback and a high level of customer service.
• Ability to influence and manage change and conflict.
• Ability to establish and maintain effective working relationships at all levels, internally and externally.
• Pragmatic decision-making and the ability to think quickly.
• Ability to interpret and apply regulations, regulatory guidance, codes, and public expectations, and recommend compliance changes as appropriate.
• Excellent interpersonal skills and the ability to remain constructive and civil in difficult situations.
• Ability to communicate professionally, clearly, precisely, and promptly, both orally and in writing, to all organizational levels.
• Experience working on a global team and sharing knowledge.
• Computer experience, including entering data into databases.
• Good analytical and problem-solving skills.
• Ability to travel domestically and internationally up to 40%, for durations of one to two weeks and sometimes on short notice.

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 non-compliance.
• Review GxP metrics to identify areas of risk and propose appropriate audit mitigation strategies.
• Support implementation of GQA management and lead-team technical strategies and improvements.
• Provide technical guidance and consultation in GQA lead-team meetings as needed.
• Plan, lead, schedule, prepare, conduct, and report complex audits and assessments of business development projects, research operations, and data integrity, internally and externally.
• Escalate risks and compliance issues appropriately.
• Meet requirements outlined in quality standards, manuals, policies, procedures, and tools.
• 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 the development of robust corrective and preventative actions.
• Participate in or lead preparation and review of standards, policies, procedures, and guidelines used to establish quality requirements.
• Participate in or lead 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.
• Provide technical expertise in developing and delivering quality and compliance education.
• Participate in external activities that build influence in business-relevant areas.
• Provide technical mentorship and training to people within and outside the organization.
• Maintain effective interpersonal and communication skills, including verbal communication and technical writing.
• Complete required training identified in the Individual Training Plan.
• Stay current with industry trends and regulatory agency interpretations of GxP requirements; attend relevant training, conferences, or association meetings and share knowledge.
• Mentor others in implementing GxP requirements.
• Participate in or lead divisional improvement efforts, including Six Sigma projects and departmental teams.

Benefits

• Company bonus eligibility for full-time equivalent employees, 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, including healthcare and/or 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