- Demonstrate a deep understanding of SEQS architecture, Quality processes, and QMS fundamentals when communicating with external parties, regulatory agencies, or business partners.
- Maintain current awareness of external legislation, guidelines, and industry practices affecting Standards and processes.
- Drives global harmonization of procedural documents to ensure clarity of content, consistency in application, and compliance with applicable Standards and regulations.
- Utilize technical writing and information development skills to create clear, concise quality system documentation. Engagement
- Engages with cross-functional teams to assess changes in processes and procedures against regulatory requirements, ensuring a comprehensive understanding of their impact on the Quality Management System (QMS), thereby facilitating the submission of document change requests.
- Identify improvement opportunities, utilize critical thinking, and apply problem-solving techniques to enhance and sustain quality and process effectiveness within SEQS.
- Provide consultation and education to others on the interpretation and practical implementation of the quality requirements from regulations and guidances associated with their area of expertise.
- Gathers and disseminates best practices through direct communication and engagement within communities of practice. Technical Leadership
- Provide leadership and influence within the broader quality organization (local and global) and across business areas to foster a strong understanding of the Lilly Quality System.
- Promote alignment, integration, and coordination with other quality systems within LRL.
- Act as the business quality assurance (BQA) representative for assigned computer systems. Works with systems owners to ensure systems used as controls are compliant with requirements.
- Collaborate with Global Business Process Owners to assess quality and compliance risks associated with their processes and support ongoing process performance monitoring within the business. Basic Requirements:
- Bachelor's Degree, preferably in a scientific or health related field
- Minimum of five years of experience in clinical development, regulatory, or safety in a regulated biotech/pharmaceutical environment.
- Experience with and knowledge of GxP guidelines and external regulations. Additional Skills/Preferences:
- GCP guidelines and external regulations expertise strongly preferred.
- Strong demonstrated interpersonal and negotiation skills.
- Excellent Communication skills (written and oral).
- Demonstrated ability to manage difficult global business issues utilizing a judgment-based approach.
- Demonstrated ability to influence business partners as well as quality leadership in decisions related to areas of expertise.
- Demonstrated ability to lead a team directly or indirectly, working effectively cross-functionally and cross-culturally in a virtual work environment, to communicate and resolve technical and complex issues.
- Strong project management skills, experience in process improvement, and the ability to be solution focused in the design and implementation of quality and process improvements.
- Demonstrated understanding of quality system management architecture, business process construct, and their interdependencies.
Additional Information:
• Travel 0%
• Indianapolis, Indiana (Onsite), this is not a remote position.
• This position is banded, and business title could fluctuate depending on what level a hire is made. Internal applicants should see internal guidelines. 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. #WeAreLilly -
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Sr. Principal Associate, Medicines Quality - Indianapolis, United States - Eli Lilly and Company
Description
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:
Medicines Quality Organization (MQO) Quality Systems partners with stakeholders across Lilly to ensure a robust Safety and Efficacy quality system and uses data to proactively drive Quality by Design for the benefit of the people we serve. The Sr. Principal Associate, MQO Quality Systems plays a pivotal role in collaborating closely with process owners, L&D, Quality colleagues, and leaders to shape and optimize the Safety and Efficacy Quality System (SEQS). This role will have a focus on the SEQS Medical Series. The Sr. Principal Associate provides QMS input and drives quality principles, consistent quality system architecture decisions, and the integration of requirements into procedures and required tools. Additionally, the Sr. Principal may lead or consult on large cross-functional quality projects, ensuring alignment with GxP regulations and adherence to Lilly's Quality Management System (QMS).
Responsibilities:
Quality Systems and Managing Change
Sr. Principal Associate, Medicines Quality professionals in Indianapolis
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Jamie Epps
General Manager | Business Development |