- Manage documents supporting the Lilly Quality System (e.g., standards, practices, and resource documents within GQS) that govern activity in business areas such as Production Practices, Cell Banking, and other associated topics. Develop and provide education, training and implementation tools to promote consistent processes.
- Provide consulting support to business areas on interpretation and implementation of Lilly global quality systems.
- Maintain knowledge of current industry trends (including involvement in industry groups / conferences) and regulatory agency interpretation of cGMP requirements. Provide understanding of GxP requirements and their application and influence regulatory standards.
- Lead and/or support the assessment, development and implementation of global quality projects in support of continual Global Quality System improvements.
- Partner with sites to assure inspection readiness for the applicable quality systems and assist with related responses. Determine and implement global actions from site inspection observations and trends.
- Host communities of practices to drive stakeholder involvement, enable consistent execution at the sites, and share best practices, and understand execution challenges across sites.
- Drive needed improvements through monitoring of key process indicators across sites, trends, audit and inspection activity, industry practices, and the external environment.
- As a subject matter expert, directly interact with health regulatory authorities during inspections and draft responses to observations as needed.
- Consult with site(s) QC/QA to resolve related quality compliance issues. Serve as mentor/coach for local process owners for applicable quality systems.Basic Requirements:
- Bachelor's Degree in scientific field (e.g., Chemistry, Bio-chemistry), engineering, or related field
- Minimum of 10 years' experience in a cGMP environment with strong knowledge of quality systems
- Experience in Active Pharmaceutical Ingredient manufacturing.
- Previous regulatory inspection readiness and inspection execution experience
- Proficient with the usage of the MS Office suite (e.g. Word, Excel, PowerPoint, Access, Project, Visio).Additional Skills/Preferences:
- Experience in the following quality systems:
- Process and Equipment Validation
- Quality Risk Management
- Drug Substance Manufacturing
- Non-sterile Drug Product Manufacturing
- GMP Utilities
- GMP Cleaning
- Detailed knowledge of European GMP's, ICH, PIC/S, and WHO
- Continuing education / master's degree or higher in science related field (e.g., Chemistry, Bio-chemistry).
- Previous facility or area start up experience, including equipment and process validation support.
- Demonstrated ability to interpret and apply standards to different situations by understanding customer needs and applying good problem-solving skills.
- Proficiency in planning and carry out tasks with a great degree of independence, and as part of a team, with minimal supervision and ability to travel.
- Demonstrated ability to communicate and deliver constructive feedback to customers, including oral, written and presentation communication skills.
- Demonstrated ability to develop business presentations and effectively communicate the concepts to a multiple range of personnel.
- Previous experience with cell cultures, chromatography, and tech transfers strongly preferred.Additional Information:
- Ability to travel (5-10%) to sites, or conferences/external training courses/association meetings
- Requires visits to manufacturing sites.
- This is a flex position though must be able to be based at a Lilly facility (Indianapolis, IN, Lebanon, IN, RTP, NC, Concord, NC, Branchburg, NJ, Kinsale, Ireland, Sesto, Italy, Fegersheim, France) with flexibility for some remote work. 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 -
Quality Systems Manager
4 days ago
Stealth Recruiting Services Indianapolis, United StatesJob Description · Job Description100k to 140k · Job Description · The Quality Systems Manager (QS Manager) ensures Quality is incorporated into the foundations of everything we do and through the life cycle of the products we create. This individual manages the design, creation, ...
-
Manager, Quality Assurance Systems
6 days ago
RayzeBio Indiana, United StatesJob Title: Manager, Quality Assurance Systems · Location: Indianapolis · Background · RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is ...
-
Quality Systems Associate/Specialist
1 week ago
RayzeBio Indianapolis, United StatesPosition: Quality Systems Associate/Specialist · Location: Indianapolis · Background · RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company i ...
-
Quality Manager for Assistance Systems
6 days ago
Skyline Enterprises Stilesville, United StatesJoin our team at Stilesville and make a difference · As part of our highly motivated and experienced team, you will work closely with interdisciplinary partners in development, supplier networks, and manufacturing. · You will be responsible for quality work in areas such as requi ...
-
2nd Shift Fork Truck Operator
1 hour ago
DOUBLE H PLASTICS INC Marion, United States**2nd Shift Hours 3 PM to 11:30 PM with rotating weekends based on production need.** · **Position Purpose: Support the Warehouse Department through the movement of raw materials, finished products, crated equipment, pallets, etc., accurately and efficiently through the facility. ...
-
Occupational Therapist Home Health
1 day ago
Angels of Mercy Homecare - Marion Marion, United States Full timeWe are hiring for a Full-Time Home Health Occupational Therapist in Marion · We offer a competitive benefits package, mileage reimbursement, and are an award-winning team We recently were recognized by our employees via Comparably as The Best Leadership Team and Best CEO for Wome ...
-
Home Health Occupational Therapist
6 days ago
LHC-Illinois Home Health Care Marion, United States Full timeWe're hiring for a full-time Home Health Occupational Therapist to join our passionate team in Marion, IL · At Illinois Home Health Care, we embrace a culture of caring, belonging, and trust and enjoy the meaningful connections that come from it: for the whole patient, their fami ...
-
Controller - Remote
3 days ago
CHE Behavioral Health Services Indianapolis, United StatesOverview: · Controller. · Remote · CHE Behavioral Health is seeking a full time Controller-Healthcare experience is required for consideration. · **About Us** · CHE is a premier provider of behavioral health services in 14 states and continues to grow into new markets. CHE has be ...
-
Renovate Building 16 Services
1 week ago
Next Level Media Marketing LLC Marion, United StatesProject Overview: · Marion VAMC Building 16 will house the Director, Executive Leadership Team, and other major administrative and operational departments of the VA Northern Indiana Health Care System. While the building will not be occupied during renovation, the project will be ...
-
Warehouse Supervisor Ii
1 week ago
Dollar General Marion, United StatesWork Where You Matter: At Dollar General, our mission is Serving Others We value each and every one of our employees. Whether you are looking to launch a new career in one of our many convenient Store locations, Distribution Centers, Store Support Center or with our Private Fleet ...
-
School Office Manager
1 day ago
Goodwill Industries of Central Indiana, Marion, United States_**This is a Monday-Friday daytime position at our brand new Excel Center serving Grant County/Marion, IN residents later this summer (position will start ASAP to assist with opening the school). The general salary range is $38-47K annually including full benefits (below)**:_ · T ...
-
Body Shop Technician II- $2,500 Sign-On
1 day ago
Penske Truck Leasing Indianapolis, United States Full timePosition Summary: · Ready to move your career forward? As a Body Shop Technician with Penske, you'll perform diagnostic procedures and truck and trailer collision repairs, and with supervision some major suspension, electrical, painting and welding repairs too. All while enjoying ...
-
Automotive Sales Consultant-buick/gmc
1 week ago
Greg Hubler Automotive Marion, United States**_GREG HUBLER AUTOMOTIVE-Driving People Forward, One Guest at a Time_** · We are so grateful to be able to serve the community of Marion, Indiana We want to be the First place (and the last place) customers come for all of their automotive needs. To that end, we are looking for ...
-
Production Control Assistant
2 days ago
Teledyne e2v Semiconductors Marion, United StatesBe visionary · Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, e ...
-
Benefits Account Manager
1 week ago
Insurance Management Group Marion, United States**WHO WE ARE**: · - At Insurance Management Group, we're driven by the opportunity we have every day to positively impact our clients, co-workers, and communities. We take pride in each and every interaction to protect and inspire, a key reason we feel we have been a successful i ...
-
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 ...
-
Training for Specialist in Food Technology
1 week ago
FusionTech Marion, United StatesWith our well-known and successful brands, we are one of the leading mineral water companies in Germany as a family-owned business. Thanks to our dedicated employees, we are able to maintain and continuously expand this position. · Starting on August 1st, 2024, we are looking for ...
-
Quantum Innovations State Center, United StatesOverview · Our client is seeking a Senior Embedded Software Engineer to join their team at State Center. In this role, you will be responsible for developing safety switchgear systems for global players in the mechanical and plant engineering industry, as well as machine users. · ...
-
Training as a machine and plant operator
1 week ago
FusionWorks Marion, United StatesAbout the Company · We are a globally leading manufacturer of high-quality wood-based materials. Since our business started in 1897 with a single sawmill, Kronospan has developed a unique supply chain with over 35 production sites and 21 distribution centers in 28 countries, and ...
-
Production worker
6 days ago
Radiant Innovations Marion Center, United StatesMarion Center is looking for a PRODUCTION WORKER (M/F/D) to join our team. We specialize in developing and producing innovative, environmentally friendly, and high-quality systems and equipment for paint processing companies. Our products are trusted by companies in over 45 count ...
Advisor - QA - Global Quality Systems - 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.
The Advisor - QA - Global Quality Systems (GQS) will establish Lilly's Quality Systems, which include Lilly Global Quality standards, business processes and IT tools. As a global expert, they consult with and educate customers on quality issues, and proactively ensure compliance of Lilly's Quality Systems with various country agency standards, industry trends and scientific principles to assure that all aspects of the operation are in compliance with regulatory expectations and Lilly quality standards. The Advisor – Global Quality Systems is responsible for monitoring the performance of the quality system and driving continuous improvement in the area of Drug Substance (API) and Dry Products for Lilly's Manufacturing of Drug Substance and Drug Product.
Key Objectives/Deliverables:
