Senior Director - GxP Learning and Development Global Process Owner (GPO)

Eli Lilly and Company; Indiana (PA); On-site; USD 150,000 - 220,000; Full time

Job summary

An established industry player seeks a Senior Director to oversee GxP Learning and Development. This pivotal role involves establishing global quality systems, leading strategic initiatives, and ensuring compliance across all manufacturing sites. The ideal candidate will possess extensive experience in the pharmaceutical sector, particularly in learning and development, with a strong understanding of GxP regulations. Join a collaborative environment where your leadership will drive significant improvements and influence the future of healthcare education. Embrace the opportunity to make a meaningful impact on a global scale.

Benefits

401(k) plan

Pension plan

Medical benefits

Dental benefits

Vision benefits

Vacation benefits

Employee assistance program

Fitness benefits

Qualifications

• 10+ years in pharmaceutical learning and development roles.
• Experience leading strategic initiatives in regulated areas.

Responsibilities

• Establish and maintain global quality system for Learning and Development.
• Lead implementation of improvement initiatives and ensure compliance.

Skills

Leadership in Learning and Development

Strategic Thinking

GxP Regulations Knowledge

Process Improvement

Data Analysis

Communication Skills

Education

Bachelor’s Degree

Master’s Degree in Adult Learning or related field

Tools

Learning Management Systems

Analytical Tools

Job description

Senior Director - GxP Learning and Development Global Process Owner (GPO) page is loaded

Senior Director - GxP Learning and Development Global Process Owner (GPO)

Apply locations US, Indianapolis IN time type Full time posted on Posted 2 Days Ago job requisition id R-85613

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.

About the job

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.

Responsibilities

The Senior Director, Global Process Owner (GPO) for GxP Learning and Development, will establish and maintain the global quality system for GxP Learning and Development. They will provide strategic oversight and expertise for global GxP Learning and Development processes, including Global Quality System standards, practices, business processes, training and implementation tools in collaboration with Human Performance Reliability, Lilly Global Learning & Development, and global and site analytic teams . Additionally, the Global Process Owner will

have accountability to integrate Learning and Development standardization for all GxP processes across all manufacturing sites as part of QMS I3 transformation as well as working within the Lilly Global Learning and Development cross-functional governance structure. The GPO will lead key global projects and priorities within the QMS I3 transformation.

The Global Process Owner will consult with the Lilly Learning and Development organization across Manufacturing, R&D, Regulatory, Clinical, Commercial Quality, external suppliers, and other global functions to educate on the quality system and proactively ensure compliance of Lilly’s Quality Systems with various country agency standards, industry trends, and scientific principles.

Key Objectives/Deliverables

The Senior Director, Global Process Owner for Learning and Development is responsible to:

• Establish and maintain the global quality system for Learning and Development to drive standardization globally across all GxP functions including all Manufacturing sites.

• Lead the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry, and company expectations.

• Ensure governance, lead the implementation of improvement initiatives, and foster a robust compliance mindset.

• Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement.

•Participate in Lilly Global Learning & Development cross-functional governance to ensure appropriate data gathering and reporting.

• Act as a SME in collaboration with Human Performance Reliability, Global Learning Services, and Quality and site analytic teams to ensure alignment with IT applications and analytical tools supporting business needs and facilitating accurate reporting and analytics for quality compliance, patient safety and manufacturing operations.

• Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance.

• Monitor performance metrics, report, and provide insights to inform decision-making to drive further improvements.

• Develop, lead, mentor, and maintain a community of cross-functional SMEs in collaboration with Human Performance Reliability, Lilly Global Learning & Development, and global and site analytic teams to collaborate on proposed improvements and deepen the knowledge of the associated processes and tools.

• Actively collaborate with enterprise-wide teams on standardized global business processes.

• As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections, and draft responses to observations as needed.

• Actively engage in external organizations and industry forums to monitor policy changes for regulatory/external environments and advocate/influence quality-related policies and regulatory requirements related to Learning and Development.

Basic Requirements:

• Bachelor’s degree

• 10+ years’ experience in the pharmaceutical industry in learning and development roles across regulated areas such as commercial Manufacturing, Quality, and Research and Development.

• 5+ years in a leadership role with strategic initiatives

• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.

Additional Skills/Preferences:

• Master’s degree preferred, in Adult Learning, Instructional Systems Technology, Performance Technology, Human Resources, or related experience/deucation.

• Deep understanding of GxP regulations
• Experience with learning and development systems/technologies•Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control.
• Experience leading a major multi-site or global functions improvement initiative.
• Strong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities.
• Proficiency in addressing operational challenges through structured approaches and innovative solutions.
• Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data.
• Demonstrated change agility in anticipating and leading others through change and ambiguity.
• Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats.
• Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity.
• Demonstrated influential leadership expertise and experience engaging with senior-level functional leads.
• Strong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results.
• Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks.
• Expertise in audit readiness and response, as well as navigating and ensuring adherence to global regulatory standards and frameworks.
• Experience leading a major multisite improvement initiative or driving multisite standardization.

Additional Information:

• Available to travel (domestic and international) when required (ca. 10%)

• Fluent in English, additional languages are also recommended.

• Role may be based in US Eastern Time Zone or EU; may be remote or located at a Lilly Quality site.

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

$150,000 - $220,000

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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