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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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Brand Description:

The Associate Vice President (AVP), Global Quality Auditing and Compliance is a leadership role within the Global Quality Compliance (GQAAC) organization. The role provides strategic leadership across auditing and compliance activities to assure compliance to external and internal requirements and continually drive improvements to enable the team to meet the needs of the corporation. The AVP provides leadership and oversight for Quality Auditing across the Lilly enterprise, including but not limited to Research and Development, Medical, Affiliates, Regulatory, Commercial Manufacturing, Suppliers and Service Providers, Computer Systems, Business Development activities and US Customer Information. The role is accountable for ensuring these activities are conducted by the company in accordance with company policies, standards and procedures as well as current global GXPs. The GXP requirements include Good Research Practices (GRP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Pharmacovigilance Practices (GVP), Good Promotional Practices (limited) and other required guidelines and regulations for human health products.

The position assures that the work by these organizations (internal and external) are performed in accordance with company expectations and in compliance with current regulations and guidelines. In addition to the auditing activities, this role also has oversight of the process owners for HR-Q processes, Business Development activities, Controlled Substance and Special Security Sunstance program, Site Compliance Reports and Inspection Support. The role also provides back up support for regulatory reporting and inspection readiness activities as required.

Key Objectives/Deliverables:

Strategic Leadership

+ Provide direction to the GQAAC organization as it executes its mission of providing assurance through auditing and proactive assessment of compliance across research and development, clinical research, manufacturing, quality, regulatory and pharmacovigilance activities.

+ The role is part of the Global Quality Compliance (GQC) senior leadership and will contribute to strategy setting, people management, project prioritization and other leadership activities across GQC.

+ Ensure appropriate staffing levels, capabilities, training, continuous development to enable proficient execution of responsibilities.

+ Complete all required HRP processes for direct employees and ensure completed for all organization.

+ Work with the GQAAC management team to set departmental strategy and objectives.

+ Lead recruiting efforts to build/maintain full complement of qualified staff.

+ Drive continuous improvement initiatives through application of appropriate methods (e.g., Six Sigma).

+ Develop, review and/or approve relevant departmental procedures and corporate quality standards as needed.

+ Ensure consistency with regulatory requirements for the content of departmental procedures and corporate standards where GQAAC is the subject matter expert.

+ Provide leadership to ensure appropriate resolution of issues.

+ Serve as a point of escalation for an independent assessment if there are concerns regarding conflict of interest.

Audit Program Oversight

+ Assure the audit and compliance programs, audit plan and execution are aligned with the areas of highest risk for the corporation.

+ Establish and implement an effective audit and compliance programs to determine and communicate the state of compliance for the corporation across the life cycle of pharmaceutical discovery, clinical trials, development, commercialization, and safety monitoring.

+ Ensure audit and compliance processes are effective and efficient and ensure qualified personnel are assigned to product/project support and audit teams; direct resources in execution of audit plan and compliance assessments.

+ Develop and deliver communications on audit findings trends and compliance assessments to senior management.

+ Escalate, lead and/or participate in the resolution of any significant compliance issues.

+ Remain current with external trends to assure that audits and compliance assessments are aligned with current expectations.

+ Drive and/or participate in issue resolution as a result of critical audit findings, significant deviations, escalations, and notification to management processes.

+ Provide support to the sites during regulatory agency inspections.

+ Provide input to significant regulatory communications such as responses to 483 citations, etc

+ Assure operational database and proactive tracking of execution of regulatory commitments for manufacturing and development.

+ On an annual basis, report the results of the evaluation along with the annual audit plan, audit results and trends to the Ethics and Compliance Committee of the Board of Directors (BOD).

+ Maintain documentation of assessments and reports to the BOD in the Corporate GxP Library.

Business Development

+ Speed Innovation by proactively providing quality/compliance inputs into External Innovation, Development and Commercial GMP and translating business needs to associated auditing and compliance strategies to assure continued compliance.

+ Provide quality leadership to ensure that appropriate quality assessment for each External Innovation due diligence project.

+ Escalate significant concerns noted in External Innovation due diligence activities to senior management

Key Objectives/Deliverables:

Strategic Leadership

+ Provide direction to the Global Quality Auditing and Compliance (GQAAC) organization as it executes its mission of providing assurance through auditing and proactive assessment of compliance across research and development, clinical research, manufacturing, quality, regulatory and pharmacovigilance activities.

+ The role is part of the GQC Sr leadership and will contribute to strategy setting, people management, project prioritization and other leadership activities across GQC.

+ Ensure appropriate staffing levels, capabilities, training, continuous development to enable proficient execution of responsibilities.

+ Complete all required HRP processes for direct employees and ensure completed for all organization.

+ Work with the GQAAC management team to set departmental strategy and objectives.

+ Lead recruiting efforts to build/maintain full complement of qualified staff.

+ Drive continuous improvement initiatives through application of appropriate methods (e.g., Six Sigma).

+ Develop, review and/or approve relevant departmental procedures and corporate quality standards as needed.

+ Ensure consistency with regulatory requirements for the content of departmental procedures and corporate standards where GQAAC is the subject matter expert.

+ Provide leadership to ensure appropriate resolution of issues.

+ Serve as a point of escalation for an independent assessment if there are concerns regarding conflict of interest.

Audit Program Oversight

+ Assure the audit and compliance programs, audit plan and execution are aligned with the areas of highest risk for the corporation.

+ Establish and implement an effective audit and compliance programs to determine and communicate the state of compliance for the corporation across the life cycle of pharmaceutical discovery, clinical trials, development, commercialization, and safety monitoring.

+ Ensure audit and compliance processes are effective and efficient and ensure qualified personnel are assigned to product/project support and audit teams; direct resources in execution of audit plan and compliance assessments.

+ Develop and deliver communications on audit findings trends and compliance assessments to senior management.

+ Escalate, lead and/or participate in the resolution of any significant compliance issues.

+ Remain current with external trends to assure that audits and compliance assessments are aligned with current expectations.

+ Drive and/or participate in issue resolution as a result of critical audit findings, significant deviations, escalations, and notification to management processes.

+ Provide support to the sites during regulatory agency inspections.

+ Provide input to significant regulatory communications such as responses to 483 citations, etc

+ Assure operational database and proactive tracking of execution of regulatory commitments for manufacturing and development.

+ On an annual basis, report the results of the evaluation along with the annual audit plan, audit results and trends to the Ethics and Compliance Committee of the Board of Directors (BOD).

+ Maintain documentation of assessments and reports to the BOD in the Corporate GxP Library

Business Development

+ Speed Innovation by proactively providing quality/compliance inputs into External Innovation, Development and Commercial GMP and translating business needs to associated auditing and compliance strategies to assure continued compliance.

+ Provide quality leadership to ensure that appropriate quality assessment for each External Innovation due diligence project.

+ Escalate significant concerns noted in External Innovation due diligence activities to senior management

Controlled Substance and SSS Program Oversight

+ Ensure that the Global Controlled Substance and SSS program remains compliant with standards, policies, procedures and guidelines that are used to establish Quality, SSS and CS requirements.

+ Ensure that Lilly Global Controlled Substance Leader maintains a relationships with relevant regulatory authorities, including facilitation of regulatory inspections for US DEA, when required and as assigned.

+ Provide oversight for development of CAPAs to address gaps identified in processes related to SSS/CS compliance.

+ Interpret regulatory and/or quality standard requirements for applicability to the business processes and respond to related questions.

+ Appropriately escalate any compliance issues.

HR-Q

+ Chair and/or participate on governance and triage meetings related to the HR-Q program, provide oversight to the program execution and effectiveness, and ensure appropriate linkages with other relevant compliance programs, including but not limited to Ethics & Compliance.

Provide Back-Up Support for Regulatory Reporting and Inspection Readiness

+ Management accountability for communications to regulatory agencies and internal customers on recalls, three-day field alert, biological product deviation reporting (BPDR), drug shortages, and other communications as appropriate.

+ Assure facilities are appropriately registered with the US FDA.

+ Accountable for the coordination of product retrieval during recalls and market withdrawals.

Minimum Requirements:

+ Minimum of 15 years of industry experience in areas including quality assurance, auditing, quality control, technical services, manufacturing operations, regulatory affairs, process or product development, medical or engineering.

+ Substantive knowledge and functional expertise in quality assurance and/or quality compliance.

+ Demonstrated ability to successfully lead teams and drive across-functional change.

Additional Preferences:

+ Ability to partner and collaborate with global manufacturing sites and technical functions.

+ Demonstrated effective communication skills.

+ Demonstrated influence with cross-functional senior leadership.

+ Demonstrated ability to interpret and apply standards to different situations by understanding valid and phase-appropriate requirements, customer needs, and applying good risk assessment and problem-solving skills.

+ Strong technical writing skills and proven ability to synthesize information from multiple sources and make risk-based decisions.

+ A deep understanding of quality systems and program management.

+ Six Sigma Black Belt or Green Belt experience.

+ Demonstrated ability to collaborate across boundaries/cultures and achieve results with internal and external partners.

+ Ability to work in a dynamic environment and deal with complexity.

+ 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 cross-functionally and manage change/conflict.

+ Establish and maintain effective working relationships at all levels internal and external to Lilly.

+ Ability to achieve pragmatic in decision making.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$234,000 - $378,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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