Principal Associate - Quality Lead, Drug Product External Manufacturing (America)

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 medical device and Packaging 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 Device assembly 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.

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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

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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