Supplier Quality – Medical Devices (Contract Manufacturing)
Eli Lilly and Company, Indianapolis, IN, United States
Overview
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 put people first and seek individuals determined to make life better for people around the world.
Organization Overview:
Indianapolis Device Manufacturing (IDM) is responsible for the development, commercialization, manufacture, and global technical stewardship of delivery devices used to administer many of the therapeutics in Lilly\'s portfolio. This includes the development and delivery of test systems and test methods in support of design verification, production, and complaint handling.
Responsibilities
The Principal Associate - Contract Manufacturing (R1-R3) or Sr. Principal Associate - Contract Manufacturing (R4) provides oversight and support to contract manufacturing operations of medical devices and combination products. The primary responsibility is to oversee the quality of the components, sub-assemblies, and finished devices manufactured at the Contract Manufacturers (CM) and supplied to Internal Lilly sites. The Quality Assurance Associate provides assistance and guidance on deviation investigations, CAPA, change control, batch release, equipment qualification, process validation, audits, complaints, design verification, and design validation.
Ensure that components, sub-assemblies, and finished devices have been manufactured and released in compliance with cGMPs
Evaluate if products manufactured at the CM meet requirements for batch release
Review/approve GMP documents for CM process manufacturing including: protocols, technical reports, deviations, change controls, inspection procedures and specifications, sampling plans, sort/rework procedures, and validation packages
Ensure that Root Cause Investigations (RCIs) are complete, corrective or preventive actions are taken, and effectiveness checks are appropriate to address quality related issues at IDM and CMs
Provide data (inputs) for management review, monthly metrics, quarterly business reviews, site compliance reporting, and post-launch risk management reporting
Participate in Failure Modes and Effects Analysis (FMEA)
Initiate and support continuous improvement projects
Assist with internal audits and supplier audits and maintain supplier management requirements
Support molding and non-molded part validation at CMs
Support design verification activities
Manage CM Quality Agreements and Quality Plans; ensure the expectations are monitored and met at the CM
Participate on joint process teams
Maintain knowledge and application of CM QMS to enable quicker, risk-based decisions relative to product quality
Coordinate process and design changes with assembly sites
Verify effectiveness activities
Additionally for R3-R4 candidates:
Perform GMP reviews for internal procedures
Conduct GQS gap assessments and establish action plans with controlling mechanism for closure
Consult/work with Regulatory to assure compliance with applicable registrations and requirements
Coach and mentor cross-functional peers
Basic Requirements
Bachelor’s Degree - Preferred in STEM discipline
1 year industry related experience
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 or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Skills/Preferences
Experience working with contract manufacturers and suppliers
Knowledge of global medical devices and combination product regulations (e.g. 21CFR820, 21CFR Part 4, Part 11, ISO 13485, ISO 11608, Canadian MDR, EU Medical Devices Directive/Regulation, JPAL, TGA, ANVISA)
Knowledge of Quality System elements and their application in a manufacturing environment
Experience with plastic molding/assembly operations
Experience with Outlook, Microsoft applications, Trackwise, Veeva, SAP, Darwin, and Master Control
Effective communication, interpersonal, and networking skill
Self-management skills
Strong attention to detail
Ability to work as part of a team
Problem solving skills
Meets commitments and deadlines
Ability to multi-task and manage competing priorities
Strong technical writing skills and proficiency in technical review of documents
Strong organizational, time management and planning skills
Additional Information
Ability to work in a dynamic and fast paced environment
Overtime may be required to meet business requirements
Some US and OUS travel will be required (approximately 10-25%)
On call by cell phone during non-business hours
This position is located at LTC-North in IDM
The job responsibilities of this position support the technical ladder process
All Lilly job postings are available in accordance with applicable laws and regulations. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume, please complete the accommodation request form for further assistance. Lilly is an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, national origin, protected veteran status, disability, or any other legally protected status. This position may involve travel and commitments outside standard hours as required by business needs.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400. Full-time employees may be eligible for a company bonus and a comprehensive benefits program including 401(k), health, dental, vision, and other benefits.
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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 put people first and seek individuals determined to make life better for people around the world.
Organization Overview:
Indianapolis Device Manufacturing (IDM) is responsible for the development, commercialization, manufacture, and global technical stewardship of delivery devices used to administer many of the therapeutics in Lilly\'s portfolio. This includes the development and delivery of test systems and test methods in support of design verification, production, and complaint handling.
Responsibilities
The Principal Associate - Contract Manufacturing (R1-R3) or Sr. Principal Associate - Contract Manufacturing (R4) provides oversight and support to contract manufacturing operations of medical devices and combination products. The primary responsibility is to oversee the quality of the components, sub-assemblies, and finished devices manufactured at the Contract Manufacturers (CM) and supplied to Internal Lilly sites. The Quality Assurance Associate provides assistance and guidance on deviation investigations, CAPA, change control, batch release, equipment qualification, process validation, audits, complaints, design verification, and design validation.
Ensure that components, sub-assemblies, and finished devices have been manufactured and released in compliance with cGMPs
Evaluate if products manufactured at the CM meet requirements for batch release
Review/approve GMP documents for CM process manufacturing including: protocols, technical reports, deviations, change controls, inspection procedures and specifications, sampling plans, sort/rework procedures, and validation packages
Ensure that Root Cause Investigations (RCIs) are complete, corrective or preventive actions are taken, and effectiveness checks are appropriate to address quality related issues at IDM and CMs
Provide data (inputs) for management review, monthly metrics, quarterly business reviews, site compliance reporting, and post-launch risk management reporting
Participate in Failure Modes and Effects Analysis (FMEA)
Initiate and support continuous improvement projects
Assist with internal audits and supplier audits and maintain supplier management requirements
Support molding and non-molded part validation at CMs
Support design verification activities
Manage CM Quality Agreements and Quality Plans; ensure the expectations are monitored and met at the CM
Participate on joint process teams
Maintain knowledge and application of CM QMS to enable quicker, risk-based decisions relative to product quality
Coordinate process and design changes with assembly sites
Verify effectiveness activities
Additionally for R3-R4 candidates:
Perform GMP reviews for internal procedures
Conduct GQS gap assessments and establish action plans with controlling mechanism for closure
Consult/work with Regulatory to assure compliance with applicable registrations and requirements
Coach and mentor cross-functional peers
Basic Requirements
Bachelor’s Degree - Preferred in STEM discipline
1 year industry related experience
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 or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Skills/Preferences
Experience working with contract manufacturers and suppliers
Knowledge of global medical devices and combination product regulations (e.g. 21CFR820, 21CFR Part 4, Part 11, ISO 13485, ISO 11608, Canadian MDR, EU Medical Devices Directive/Regulation, JPAL, TGA, ANVISA)
Knowledge of Quality System elements and their application in a manufacturing environment
Experience with plastic molding/assembly operations
Experience with Outlook, Microsoft applications, Trackwise, Veeva, SAP, Darwin, and Master Control
Effective communication, interpersonal, and networking skill
Self-management skills
Strong attention to detail
Ability to work as part of a team
Problem solving skills
Meets commitments and deadlines
Ability to multi-task and manage competing priorities
Strong technical writing skills and proficiency in technical review of documents
Strong organizational, time management and planning skills
Additional Information
Ability to work in a dynamic and fast paced environment
Overtime may be required to meet business requirements
Some US and OUS travel will be required (approximately 10-25%)
On call by cell phone during non-business hours
This position is located at LTC-North in IDM
The job responsibilities of this position support the technical ladder process
All Lilly job postings are available in accordance with applicable laws and regulations. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume, please complete the accommodation request form for further assistance. Lilly is an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, national origin, protected veteran status, disability, or any other legally protected status. This position may involve travel and commitments outside standard hours as required by business needs.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400. Full-time employees may be eligible for a company bonus and a comprehensive benefits program including 401(k), health, dental, vision, and other benefits.
#J-18808-Ljbffr