- _General QMS responsibilities_
- Be a change agent for the One Lilly QMS transformation program advocating for its adoption within the Parenteral network.
- Participate in all required general QMS workshops and team meetings.
- Provide network specific input to other QMS workstreams as requested.
- Support general QMS Organizational Change Management activities within the Parenteral network including facilitation of cross-functional education sessions and training programs.
- Support deployment activities for Parenteral sites globally.
- _Deviation Specific responsibilities_
- Consult with key Parenteral Network stakeholders to generate an ideal future state process map for Deviation Management
- Support the detailed deviation and CAPA design sessions for the One Lilly QMS transformation program, providing network specific inputs and seeking additional network SME input as required.
- Connect with stakeholders in network and make informed design decisions on behalf of the Parenteral network.
- Socialize all analytical investigation related changes within their network to ensure broad acceptance of proposed solutions.
- Be a change agent for the overall future state deviation management system and process advocating for its adoption within their network.
- Support all necessary validation activities and identify additional Parenteral SMEs to support as necessary.
- Support development of deployment plans within Parenteral network and more broadly to all business areas around the company as necessary
- Act as primary deployment lead for Parenteral Network globally, ensuring adequate local site representation is available for full site deployment.
- Support overhaul of Parenteral network specific documentation (including providing guidance on local site procedures) and training programs to align with streamlined global approach.
- Design and deliver global and/or Parenteral specific documentation and training content in collaboration with training SME and system integrator SMEs.
- Escalate Parenteral specific concerns/issues and develop mitigation plans.
- Support establishment of Deviation Center for Enablement by designing and delivering deviation related programs globally (e.g. Deviation conferences, enhanced deviation communications, deviation reward and recognition programs etc.)
- BS, MS, or PhD in a field of science, engineering, pharmacy, or medicine.
- Minimum 10-year experience in the pharmaceutical industry, in areas of cGMPs/cGxP's
- Extensive hands on deviation management and analytical investigation experience required. Hands on experience with other QMS processes desired.
- Lean, 6 sigma, Black Belt, or Competitive Continuous Improvement coach experience preferred
- Demonstrated leadership acumen, including project leadership
- Demonstrated ability to build and maintain collaborative relationships with external/internal stakeholders; navigate complex issues and find common ground with multiple constituencies with differing, and often opposing, perspectives.
- Strong collaboration, negotiation, problem solving, and interpersonal skills. Proven record of finding and implementing solutions.
- Demonstrated ability to write technical documents, develop business presentations, and effectively communicate the concepts to a wide range of personnel.
- Ability to travel (domestic and internationally).
- Potential for role to be based at any Lilly M&Q site.
-
Principal, Associate Principal,
4 weeks ago
Indianapolis Symphony Orchestra Indianapolis, United States Full timeINDIANAPOLIS SYMPHONY ORCHESTRA · Audition to be held: · June 16-19, 2024 · Deposit Check must be postmarked by May 1, 2024. · Further information regarding the audition can be found at: · The Indianapolis Symphony is a 42 playing-week orchestra located in Indianapolis, IN and mo ...
-
Principal Associate
1 week ago
Eli Lilly and Company Indianapolis, United States Full timeAt 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 th ...
-
Principal Associate
4 weeks ago
Eli Lilly and Company Indianapolis, United States Full timeAt 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 th ...
-
Sr. Principal Associate
4 days ago
Eli Lilly and Company Indianapolis, United States Full timeAt 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 th ...
-
Sr Principal Associate
2 weeks ago
Eli Lilly and Company Indianapolis, United States Full timeAt 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 th ...
-
Sr. Principal Associate, Medicines Quality
1 week ago
Eli Lilly and Company Indianapolis, United States Full timeAt 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 th ...
-
hendricks regional health ymca- gym monitor
2 weeks ago
YMCA of Greater Indianapolis , IN, United StatesYMCA of Greater Indianapolis Position Description Title: Gym Monitor Association: Greater Indianapolis Reports to: Youth Family/ Teen/ Sports Director Center: FLSA: Non-Exempt/ Part-time Date: March 2019 Grade: I YMCA Mission To put Christian princip Health, Regional, Program, In ...
-
Behavior Adjustment Facilitator 24/25 SY
1 week ago
Indiana Public Schools Indianapolis, United StatesSUMMARY OF ESSENTIAL JOB FUNCTIONS: · Will work with students, teachers, and parents to reduce the number of suspensions, expulsions, and exclusions of students by performing the following duties. · QUALIFICATIONS: · Sixty semester hours; or an Associates Degree or higher; or suc ...
-
Accident Litigation Associate
1 week ago
Scopelitis Law Firm Indianapolis, United StatesScopelitis, Garvin, Light, Hanson & Feary, a national law firm with offices located in major cities throughout the United States, is looking for an attorney with 1-3 years of experience in civil litigation for an associate position in the Firm's Highway Accident, Wrongful Death a ...
-
Head Wrestling Coach SY 24/25
1 week ago
Indiana Public Schools Indianapolis, United StatesSummary · The Head Wrestling Coach is responsible for all coaching related activities, developing and sustaining a successful program with a strong emphasis in skill development, sportsmanship, teamwork, developing character with a high degree of discipline. The Head Wrestling Co ...
-
Sr Clinical Research Coordinator
1 week ago
Community Health Network Indianapolis, United StatesJoin Community · Community Health Network was created by our neighbors, for our neighbors. Over 60 years later, "community" is still the heart of our organization. It means providing our neighbors with the best care possible, backed by state-of-the-art technology. It means gettin ...
-
Design Principal, Architect
3 days ago
BSA Lifestructures Inc Indianapolis, United StatesJob Description · Job DescriptionBSA LifeStructures is looking for a licensed Architect to serve as a Design Principal for our Indianapolis studio. This is an exceptional opportunity for a design focused Architect that wants to help foster the firm's strategy for enhanced design ...
-
Work Based Learning Receptionist
1 week ago
Metropolitan School District of Warren Township Indianapolis, United StatesPosition Type: · Secretarial/Clerical/Receptionist · Date Posted: · 5/3/2024 · Location: · Walker Career Center · Closing Date: · Until filledJOB TITLE: School Receptionist (General Assignment) · FLSA CLASSIFICATION: Non-exempt, hourly employee. · WORK DAYS: 200 days (including p ...
-
Registered Nurse
2 days ago
eCommunity , IN, United StatesJoin Community · Community Health Network was created by our neighbors, for our neighbors. Over 60 years later, community is still the heart of our organization. It means providing our neighbors with the best care possible, backed by state-of-the-art technology. It means getting ...
-
Executive Assistant
1 week ago
Simon Property Group Inc Indianapolis, United StatesJob Location: · Corporate Indianapolis · PRIMARY PURPOSE: This position is responsible for providing support in an administrative capacity for the Executive Vice-President for Simon Brand Ventures (SBV) and the Vice President of Financial reporting that supports SBV. This positio ...
-
Assistant Football Coach
1 week ago
Indiana Public Schools Indianapolis, United StatesSummary · The Assistant Football Coach is responsible for assisting the head Football coach with all coaching related activities, developing and sustaining a successful program with a strong emphasis in skill development, sportsmanship, teamwork, developing character with a high ...
-
Indiana Public Schools Indianapolis, United StatesTITLE: Deputy Title IX Coordinator and Legal Analyst- Office of General Counsel (Legal Compliance) · WHO WE ARE: · Indianapolis Public Schools (IPS) is a student-focused, innovative educational organization committed to academic excellence. Our mission is to empower and educate a ...
-
Registered Nurse
2 days ago
Community Health Network Indianapolis, IN, United StatesJoin Community · Community Health Network was created by our neighbors, for our neighbors. Over 60 years later, "community" is still the heart of our organization. It means providing our neighbors with the best care possible, backed by state-of-the-art technology. It means gettin ...
-
Middle School Assistant Flag Football Coach
1 week ago
Indiana Public Schools Indianapolis, United StatesSummary · The Assistant Head Football Coach is responsible for all coaching related activities, developing and sustaining a successful program with a strong emphasis on skill development, sportsmanship, teamwork, developing character with a high degree of discipline. The Assistan ...
-
Indiana Public Schools Indianapolis, United StatesSUMMARY · Performs any combination of the following instructional tasks to assist teaching staff of elementary or secondary school students (preschool through 22 years of age). Other duties may also be assigned by the teacher, principal, and/or Director of Special Education or de ...
Sr Principal Associate - Indianapolis, United States - Lilly
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.Position Description
The Sr Principal Associate - QA, QMS Deviation Lead - Parenteral Network represents their network for the One Lilly QMS transformation program, modifying the way we execute core quality processes (e.g., deviations, CAPA, changes, complaints, supplier quality management, auditing) across the Lilly enterprise.
The Parenteral Network lead supports design and deployment of our core quality management system processes (with primary focus on Deviation Management), the related eQMS tool, and advanced technological capabilities (e.g., artificial intelligence).
This position includes establishing and transforming processes that will sustain compliance and support continuous quality improvements throughout Lilly's GxP operations.
The role is a key influencer in the design and implementation of our future transformed QMS.Key Objectives/Deliverables:
The Sr Principal Associate - QA, QMS Deviation Lead - Parenteral Network is responsible for:
Basic Qualifications
Additional Skills/Preferences:
Additional Information
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 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