Associate - QA- IDAP Commercialization - Indianapolis, IN

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 th ...

Job 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.

Company Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Brand Description

The Sr Principal Consultant/Advisor Quality Assurance - Commercialization is primarily responsible for QA oversight for commercialization of the Indianapolis Device Assembly and Packaging (IDAP) product portfolio at the site. They will represent Indianapolis Device Assembly and Packaging QA on regulatory review, providing oversight for technology transfers, CT supply, process validations, regulatory submissions, Response to Questions and launch of new products from IDAP.

Responsibilities

• Works with site management and TS/MS to develop and facilitate the site's commercialization mission by enabling introduction of new products, NILEX (new line extensions), and clinical trials supply into Indianapolis Device Assembly and Packaging.
• Provides Quality oversight of commercialization deliverables (e.g., CT strategies, technology transfers, product control strategies, process validations, regulatory submissions, Response-to-Questions, launch plan, etc.) to ensure smooth progression of products through the commercial pipeline.
• Provides QA support for the development and oversight of the integrated Manufacturing Control Strategy (iMCS) and Risk Assessments.
• Ensures quality operational readiness to meet aggressive product launch timelines according to the single process map and commercialization model.
• Performs batch release for CT, launch and commercial materials.
• Participates in product development reviews to ensure appropriate design for manufacturability.
• The Sr Principal Consultant/Advisor QA – Commercialization has authority to approve site documents that procedurally require quality approval at the M2/R4/P4 level: deviations, change controls, technical documents, risk assessments, etc.

Basic Requirements

• Bachelor's degree or equivalent in a relevant scientific or technical field.
• Minimum of 10 years of Pharmaceutical experience.
• Minimum of 5 years of Quality 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 Preferences

• Strong interpersonal and communication skills.
• Previous demonstration of strong leadership skills.
• Demonstrated problem solving skills and a broad knowledge of IDAP operations, quality systems, and global quality standards.
• Knowledgeable of development quality system, biotech product regulations, ICH requirements, and product commercialization.
• In addition, the candidate must possess a solid understanding of the importance of and basic requirements of Regulatory agencies such as the FDA and EMA, particularly in the area of cGMPs.
• Demonstrated solid judgment and initiative.
• Enthusiastic, positive attitude, flexible, and willing to work overtime.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and site goals.
• The position is for first shift, however, overtime and flexibility in shift will be required; must be flexible to attend meetings or support off-shifts as necessary.
• Applicant may work in various areas within the IDAP plant. Some allergens are present in the IDAP plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
• Project delivery and/or plant shutdowns may coincide with company holidays.
• Occasional travel may be required for training, conferences, capital projects, etc.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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 equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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