Lilly Commercialization QA Lead - Drug Product External Manufacturing in SESTO FIORENTINO, Italy
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 35,000 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.
Drug Product External Manufacturing (DPEM) Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. DPEM Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.
The Quality Assurance Commercialization Lead is primarily responsible for QA oversight for commercialization of the parenteral product portfolio within DPEM. The QA Lead will represent DPEM QA on the CMC teams, providing oversight for technology transfers, process validations, regulatory submissions, Response to Questions and launch of new products from DPEM Contract Manufacturers.
Works with DPEM management and TS/MS to develop and facilitate the site's commercialization mission by enabling introduction of new products, NILEX (new line extensions) within DPEM Contract Manufacturers.
Provides Quality oversight of commercialization deliverables (e.g., 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 Manufacturing Control Strategy.
Development of relationships with Contract Manufacturing peers to drive effective communication.
Ensures quality operational readiness to meet aggressive product launch timelines according to the single process map and commercialization model.
Participates in product development reviews to ensure appropriate design for manufacturability.
Pre-Approval Inspection Readiness support
The QA Lead – Commercialization has authority to approve DPEM documents that procedurally require quality approval at the Assoc Director level: deviations, change controls, technical documents, risk assessments, etc.
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and site goals.
Product and DPEM Support:
Participate in the creation and revision of standard operating procedures
Work with Lilly support groups to resolve product related issues
Participate on Commercialization transition to Joint Process Teams
Be involved with Lean/Continuous Improvement projects to help improve productivity
BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences or equivalent experience
Minimum 7 years of experience in pharmaceutical manufacturing and/or related areas
Experience in Lilly electronic quality systems (Trackwise, Veeva)
Technical knowledge of pharmaceutical manufacturing
Coaching and mentoring skills
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.
Experience working with development quality system, biotech product regulations, ICH requirements, and product commercialization.
In addition, the candidate must possess a solid understanding of the importance of Regulatory agencies such as the FDA and EMA, particularly in the area of cGMPs.
Demonstrated solid judgment and initiative.
Shift is days, but off-hours may be necessary to support operations
Some travel is possible (<20%)
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