Senior Manager of Quality Assurance

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 

Position Overview

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 39,000 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.

Position Description

Sr. Manager Quality Assurance (QA) Parenteral is responsible for the staffing, training, and leadership of the quality assurance group supporting the project/expansion delivery, process development, operational readiness, start up, and validation/qualification of the parenteral process including dispensing, equipment preparation, formulation, filling and visual inspection.  The Sr. Manager will help build a strong quality culture and lead the QA team for oversight and support of the ongoing operation as well as site inspection readiness and execution.

On Site Shift Schedule: Monday to Friday 4pm to 12:30am Subject to change as needed

Direct Reports: Night shift team 6pm to 6am

Key Objectives / Deliverables

·        The Night Shift Sr. Manager, Quality Assurance, will support the start-up and routine operation of the QA organization overseeing Parenteral operations at Lilly's Kenosha, Wisconsin pharmaceutical manufacturing site. Responsibilities include technical and administrative leadership, as well as project management.

·        Serve as technical resource to review and approve technical documents 

·        Network with cross-functional technical project delivery team to ensure equipment and systems comply with quality requirements and are implemented with a Quality by Design framework 

·        Work with the Associate Director, Quality Assurance to support the development of the vision, strategy and quality culture for the overall site quality assurance organization with focus on the formulation, filling and visual inspection programs

·        Support initial recruiting, build capability, for a diverse leadership and quality assurance staff to support qualification, validation and routine production 

·        Manage a team of up to approximately 8-12 direct reports

·        Support the site to ensure a safe work environment including supporting and leading safety efforts for your team 

·        Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures and controls 

·        Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group 

·        Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment 

·        Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc. 

·        Network with global and other parenteral sites to understand best practices and share knowledge

·        Work cross-functionally with the area process teams for metrics reviews, operational support, and issue/deviation management

·        Support inspection readiness activities

·        Interact with regulatory agencies during inspections regarding cGMP issues

·        Ensure data integrity by design

Requirements (Education, Experience, Training):

• Bachelor's degree in a science, engineering, or related field of study

·        5+ years in pharmaceutical leadership including leading or working effectively with a cross-functional group

• Excellent interpersonal, written and oral communication skills

• Strong technical aptitude and ability to train and mentor others

·        Ability to work overtime as required 

·        Ability to travel 10-25% to other Lilly sites for training/meetings

·        May be required to respond to operational issues outside of core business hours and days

Preferred attributes but not required:

·        Commit to successfully maintain Lilly Computer System Quality Assurance (CSQA) Certification

·        Strong knowledge of Quality Management Systems and applicable regulatory requirements 

·        Previous experience directly supporting a pharmaceutical manufacturing operation 

·        Excellent interpersonal, written and oral communication skills

·        Strong technical aptitude and ability to train and mentor others 

·        Demonstrated technical writing skills

·        Demonstrated problem-solving and decision-making skills

·        Previous facility or area start up experience 

·        Previous equipment qualification and process validation experience 

·        Previous experience with highly automated syringe filling, vial filling, and visual inspection equipment 

·        Previous experience with Manufacturing Execution Systems and electronic batch release 

·        CQM, CQE, or CQA certification from the American Society for Quality (ASQ) 

·        Previous experience with deviation and change management systems including Trackwise, MasterConrrol, and Veeva

Additional Information

This job specification is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification.  As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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.

#WeAreLilly