Consultant-Quality Assurance (Commercialization)

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 Consultant Quality Assurance - Commercialization is primarily responsible for QA oversight for commercialization of the parenteral product portfolio at the site. This individual will represent Indianapolis Parenteral Manufacturing QA on the CMC teams, providing oversight for technology transfers, CT supply, process validations, regulatory submissions, Response to Questions and launch of new products from IPM.
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 Indy Parenteral.
• 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.
• QA support for the development and oversight of the integrated Manufacturing Control Strategy (iMCS).
• Ensures quality operational readiness to meet bold product launch timelines according to the single process map and commercialization model.
• Assist in product development reviews to ensure appropriate design for manufacturability.
• The Consultant QA - Commercialization has authority to approve site documents that procedurally require quality approval at the manager level: deviations, change controls, technical documents, risk assessments, etc.

Basic Qualifications:

• Bachelor's degree required. Degree in relevant scientific or technical field preferred.
• 3 or more years experience with Commissioning and Qualification in a manufacturing environment preferred.
• Previous demonstration of strong leadership skills.
• Strong interpersonal and communication skills.
• Demonstrated problem solving skills and a broad knowledge of Parenteral 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 judgment skills and initiative.
• Hard-working, positive outlook, flexible and adaptable.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and site goals.

Additional Information:

• The position is for first shift, however, overtime and shift flexibility may be required; must be flexible to attend meetings or support off-shifts as vital.
• Applicant may work in various areas within the Parenteral plant. Some allergens are present in the Parenteral 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.

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