Sr. Principal Associate - Indianapolis, United States - BioSpace

Description

Job Details

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:
Global Quality Compliance (GQC) is integrated into the product journey from research and development through clinical investigations and commercial production. Our role is to establish and maintain the global quality systems which safeguard patient trust. As a member of the GQC family, External Engagement and Advocacy (EEA) is focused on ensuring internal quality practices for producing and developing medicines meet global regulatory expectations, and for enabling Lilly to be a leader in shaping the external environment towards harmonization and patient centricity.

Responsibilities:

The Senior Principal Association- Global Quality Compliance External Monitoring is the outward facing front door for EEA and GQC. This role requires curiosity, expertise in quality system requirements, and attention to detail. We need someone who can connect the dots and signals coming in from around the globe, understand what matters to Lilly and send the information to key internal stakeholders for evaluation of potential impact on Lilly Quality systems. The opportunity to work with new knowledge management technology is also part of this role.

Key Objectives/Deliverables:

• Provide external monitoring services to ensure the Lilly Quality System is aligned with current expectations from regulatory bodies, industry standards, and business requirements.

o Monitor designated external sources regularly for quality and regulatory intelligence with potential to impact quality systems across the enterprise. Scope defined by the External Monitoring procedures.

o Maintain continual awareness of industry trends and regulatory agency interpretation of CGxP requirements as applicable to Lilly quality systems.

o Triage and disposition monitoring data; engage key stakeholders as needed.

o Collaborate with Q system gate keepers and standard owners to maintain Lilly quality system in alignment with regulation and industry standards.

o Define and generate system and business process metrics to ensure compliance requirements are being met and to promote efficient collaboration.

• Act as expert resource to provide awareness of key information and trends from external signals to strategic partners across the enterprise.

o Communicate external intelligence highlights and summaries to both senior quality leadership and impacted Lilly personnel via newsletters or presentations or similar means.

o Provide consulting support on regulatory body, industry, and business expectations within the scope of eternal monitoring; research topics as required.

o Develop and provide tools to allow for easy access to external documents of relevance to promote Lilly personnel continuing education on GxP requirements.

• Act as subject matter expert for external monitoring technology solutions such as MetricStream RCM

o Troubleshoot and identify issues; propose and implement improvements and enhancements to increase efficiency.

o Lead and/or support external monitoring technology enhancements, including performing informal system testing.

o Collaborate with , Business Quality Leads, and others to ensure maintenance to external monitoring tools, including requesting upgrades, managing data, maintaining configuration files, testing IT fixes, coordinating software upgrades, etc.

o Provide user coaching and contribute to the development of related training materials.

o Maintain or create business documentation to improve system user experiences including FAQs, Business Process Guide, How To videos, etc.

• Represent the business needs of GQC and EEA in the development, implementation, and maintenance of technology and knowledge management approaches to support external monitoring

o Determine and advocate for when a business process needs to change to fit the IT solution, and when the IT solution needs to be customized to fit a business process.

o Elicit and understand system enhancement needs from various business areas, and help determine and advocate for a specific prioritization of those needs.

o Support increasing use of artificial intelligence and digitalization.

Basic Requirements:

• Bachelor's Degree (scientific discipline preferred).

• Minimum of 10-15 years of direct experience in one or more areas subject to GMP, GCP and/or GLP.

• Experience in varied regulatory settings (e.g., Regulatory Affairs, Medical, GCP, GLP, GMP).

• Robust knowledge of GxP and Quality Management Systems.

• Expertise in program management.

• Proficient with the usage of suite of Microsoft Office products.

Additional Skills/Preferences:

• Curiosity and willingness to learn including: how health authorities work, how impact assessments are done, and what are current concerns of regulators

• Strong internal Lilly network to quickly gain insights or impact levels

• Able to attend training courses, conferences, or association meetings to continue to gain knowledge in GxPs, to share such information with other members of the QST group, other Lilly personnel, or externally to increase awareness and to train others in the implementation of these practices.

• Prior experience with software or other projects run within an Agile/Scrum framework

• Ability to develop a vision, the strategy for implementation, and specific actions for execution while identifying and implementing improvements.

• Ability to interpret information and apply it; taking relevant information from one area and applying it to another, i.e., "connecting the dots."

• Attention to detail balanced with ability to review large volumes of publications and identify new or changed information

• Effective communication skills including oral, written and presentation skills to share information effectively across a range of personnel

• Proficiency in planning and carrying out tasks with great degree of independence as part of a team, with minimal supervision.

• Ability to influence diverse groups and effectively manage relationships.

• Thorough technical understanding of quality systems and regulatory requirements across the enterprise

Additional Information:

• Less than 10 percent US and international travel is required.
• Flex hours possible.
• Business title may vary depending on level.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

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