Associate Director - Quality Assurance - Device Assembly

Regulatory Jobs; Pleasant Prairie (WI); Presencial; USD 123 000 - 198 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Flex hours possible

Travel 10-20%

Short-term assignment (6-9 months)

Resumo da oferta

Lilly is expanding its manufacturing footprint and seeks an Associate Director, QA - Device Assembly in Kenosha, Wisconsin. You will staff and lead the QA group supporting start-up activities, oversee qualification/validation of the facility and equipment, and drive a robust quality culture across operations.

The role requires on-site presence, cross-functional collaboration, and leadership in inspections readiness and regulatory interactions.

Qualificações

• Bachelor's degree in science, engineering, or pharmaceutical-related field or equivalent experience.
• Minimum 5 years' experience in pharmaceutical leadership with QA experience; cross-functional work.
• Minimum 5 years' experience directly supporting a pharmaceutical manufacturing operation (device assembly preferred).
• On-site presence required.

Responsabilidades

• Support development of site organization and Quality Management System implementation plan.
• Ensure safe work environment and lead safety efforts for the quality team.
• Approve operational procedures for Device Assembly and Packaging (DAP).
• Build a diverse and capable site organization for quality oversight and compliance.
• Foster a strong quality culture and promote teamwork and participation.
• Supervise, coach, and develop staff; manage performance and fairness.
• Manage multiple priorities to meet established due dates.
• Partner with production and design to ensure 24/7 QA oversight.
• Lead inspection readiness activities and liaise with regulatory agencies.

Conhecimentos

Quality leadership

Quality Management Systems

Regulatory inspection readiness

Facility start-up experience

SAP or inventory systems

MES / electronic batch release

Deviation & change management (Veeva)

Interpersonal communication

Formação académica

Science/engineering/pharma degree or equivalent

Ferramentas

SAP

Veeva

MES

Descrição da oferta de emprego

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.

Organization 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 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. .

Position Overview

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance leaders to support our growth in Kenosha County, Wisconsin. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Associate Director, Quality Assurance (QA) - Device Assembly (DA), is responsible for staffing, training, and leadership of the quality assurance group supporting the start‑up of combination product device assembly and operations at the Kenosha site. This individual is responsible for quality oversight of process development, operational readiness, qualification, and validation of the facility and its associated equipment. The Associate Director will help build a strong quality culture at the site and lead the QA team ensuring robust oversight and support of the ongoing operation as well as the site inspection readiness agenda.

Responsibilities

• Support the Sr. Director, QA, in the development of the site organization, creation of the Quality Management System implementation plan, and execution of site quality operations in Device Assembly and Packaging (DAP).
• Support the site to ensure a safe work environment including supporting and leading safety efforts for the quality team.
• Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures for DAP.
• Build a diverse and capable site organization to provide quality oversight and ensure compliance with area procedures and controls for device assembly.
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
• Supervise, coach, and aid in development, performance management, ensure a fair and equitable work environment.
• Engage team and delegate to achieve results through others to deliver according to plan.
• Manage multiple priorities in a fast-paced environment and deliver in accordance with established due dates.
• Demonstrate flexibility with quick response as priorities change or issues arise.
• Partner with production and design organization to ensure 24/7 Quality oversight and support.
• Engage and support Operational Excellence initiatives for monitoring performance and continuously improving the operation.
• Review and approve GMP documentation including qualification/validation protocols and reports, procedures, deviations, technical reports, change controls, for DA operations.
• Network with global and other DA sites to understand best practices, share knowledge.
• Work cross-functionally with the area process teams/flow team for metrics reviews, operational support, and issue/deviation management.
• Set area human resource and business plan goals.
• Participate in tactical and strategic business planning.
• Communicate on project and production status.
• Define, lead and/or support inspection readiness activities for operations and interact with Regulatory agencies during inspections.

Basic Requirements

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
• Minimum 5 years' experience in pharmaceutical leadership with QA experience, including leading or working effectively with a cross-functional group
• Minimum 5 years' experience directly supporting a pharmaceutical manufacturing operation (preferably device assembly operations)
• On-site presence required

Additional Skills/Preferences

• Strong knowledge of Quality Management Systems and applicable regulatory requirements
• Previous regulatory inspection readiness and inspection execution experience
• Previous facility or area start up experience
• Previous equipment qualification and process validation experience
• Previous experience with SAP or other inventory management systems
• Previous experience with highly automated combination products, packaging, and warehouse operations
• Previous experience with Manufacturing Execution Systems and electronic batch release
• Previous experience with automated material movement (central palletizing operation, automated warehousing)
• Previous experience with deviation and change management systems such as Veeva
• 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

Additional Information

• Flex hours possible
• Primary location is Kenosha, Wisconsin
• Ability to travel (approximately 10-20 %)
• Ability for Short Term Assignment (6-9 Months) in a Device Assembly and Packaging site prior to starting the role

This job description 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 description. For GMP purposes, the job description should be updated for significant changes. 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 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

$123,000 - $198,000

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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