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.

Position Brand Description:

Drug Product External Manufacturing (DPEM) Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of North, and South American 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 QA Lead for contract manufacturers (CMs) provides daily oversight, assistance, and guidance to issues such as deviation investigations, change control proposals, procedure/ master formula revisions, validations and other duties associated with daily CM activities. This role provides and assures compliance to Lilly GQS by resolving identified procedural gaps and is responsible for assuring the CM maintains a state of control with regards to manufacturing, Device assembly and/or packaging product. The QA Lead is integral for maintaining GMP compliance and providing support during preparations for Pre-Approval/ General inspections by various agencies. The QA Lead is integral for launching new products, packages, processes, and CM's.

Key Objectives/Deliverables:

• Lead/ provide support to launch new products/ packages/ CMs.

• Provide guidance and quality oversight of CMs manufacturing, Device assembly and packaging, the batch disposition process and maintenance/improvements of their quality systems.

• Evaluate issues, deviations, change controls and disposition batches countermeasures.

• Participate on Joint Process Teams

• Originate and investigate deviations associated with batch records and other DPEM activities.

• Work with Lilly support groups to resolve product related issues.

• Provide final approval of Certificates of Analysis or other similar documentation for internal and external customers.

• Provide support on site or remotely during inspections and maintain awareness of internal audit findings and external regulatory agency inspections.

• Provide assistance and guidance in Standard Operating Procedure revisions, Master Batch Record revisions, Master Packaging Order revisions and Process Validations

• Review and approve documentation that supports manufacturing (e.g., deviations, changes, procedures, protocols), as applicable.

• Author and track compliance to the CM Quality Agreements and CM Quality Plans

• Routinely have face-to-face communications with CMs

• Track and monitor Quality metrics for trends at the CM

• Support Qualifications/ Validation document creation and reviews

• Provide and coordinate designated sections for Annual Reports and Annual Product Reviews

• Execute SOP assessments of CMs and track completion of outstanding issues

• Provide support for Notification to Management data gathering

• Provide input for metrics reports to management

• Establish, maintain, improve, and monitor effectiveness of DPEM Data integrity program

• Ensure compliance to DI guidelines

• Complete other duties as assigned

Basic Requirements:

• At least 5 years of experience in pharmaceutical or medical device manufacturing/quality

• Bachelor's Degree in a science related field such as Engineering, Pharmacy, Chemistry, Biological Sciences or related Life Sciences or equivalent experience

Additional Preferences:

• Proven ability to work independently or as part of a Team to problem solve

• Experience with Lilly electronic systems (SAP, Trackwise, Regulus) and computer system validation.

• Experience with DI for drug product manufacturing and packaging processes

• Ability to conduct GMP activities.

• Experience developing and maintaining specification systems for raw materials, components, drug product, and finished product.

• At least 5 years’ experience directly supporting a manufacturing and packaging operations.

• Proficiency in leading root cause investigations and self-inspections

• Project management skills

• Coaching and mentoring skills

• Technical understanding of cGMPs and the Global Quality Standards

• Knowledge of Pharmaceutical Manufacturing Operations

• Strong written and verbal communication skills

• Teamwork and interpersonal skills exhibited across functional areas

• Ability to organize, prioritize, multi-task, and influence diverse groups

• Strong decision making and problem solving skills

Other Information:

• Shift is days, but off-hours may be necessary to support operations

• Domestic and International travel is possible, 10 – 25%

• Position is required to be onsite at Lilly Corporate Center the majority of the time.

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 ( LillyRecruitingCompliance@lists.lilly.com ) 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.

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