Associate Director - Device Quality

Eli Lilly and Company; Indianapolis (IN); On-site; USD 118,000 - 174,000; Full time

Job summary

A leading healthcare company is seeking a Quality Assurance Associate Director in Indianapolis. The role involves overseeing quality operations within contract manufacturing and ensuring compliance with regulations. Ideal candidates will have a Bachelor's degree and a minimum of five years of relevant experience, along with strong leadership and communication skills. This position offers a competitive salary and comprehensive benefits.

Benefits

Company-sponsored 401(k)

Pension benefits

Flexible benefits

Life insurance

Employee assistance program

Qualifications

• Minimum of five (5) years industry related experience in Quality, Technical Services, or Manufacturing.
• Ability to influence diverse groups and work with cross-functional teams.

Responsibilities

• Oversee quality assurance and quality control of device contract manufacturing.
• Ensure compliance with quality policies and manage quality system requirements.
• Mentor team members and provide technical understanding regarding QMS.

Skills

Leadership

Interpersonal Skills

Problem-Solving

Communication

Teamwork

Education

Bachelor’s Degree

Job description

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:

The IDM (Indianapolis Device Manufacturing) Quality Assurance Associate Director is primarily responsible for quality assurance and quality control oversight of device contract manufacturing (CM) organizations including molding, sub-assembly and assembly operations.

Key Objectives/ Deliverables:

• Ensure an adequate number of qualified resources are available to perform quality assurance activities in support of IDM quality operations and CM Quality operations
• Ensure adherence to the quality policy and objectives for the site
• Provide technical understanding and internal/external communication (throughout various functions and organization levels) regarding the Quality Management System to ensure on-going management of quality system requirements in order to maintain compliance and drive continuous improvement activities
• Participate in and respond to regulatory agency and self-inspections internal to IDM as well as providing support to CM Quality audits
• Review/approve or reject procedures and training, device master records, technical protocols and reports, change proposals, deviations and ensure implementation of appropriate corrections/CAPA and effectiveness checks
• Mentor, coach and provide feedback to team members and cross-functional partners
• Participate in organizational and business planning activities
• Exhibit cross-functional influence
• Aid in human resource planning, development and performance management for direct reports
• Identify barriers to productivity within the unit operation and drive continuous improvement
• Other duties as required

Basic Requirements:

• Bachelor’s Degree (or equivalent work experience)
• Minimum of five (5) years industry related experience in areas which may include Quality, Technical Services, and/or Manufacturing

Additional Preferences:

• Demonstrated leadership capability
• Demonstrated interpersonal skill for work with cross-functional teams, suppliers and contract manufacturers
• Ability to influence diverse groups
• Demonstrated oral and written communication
• Demonstrate self-management/time-management skills
• Meets commitments and deadlines
• Demonstrated decision-making and problem-solving skills
• Ability to work as part of a team
• Negotiating, mentoring
• Knowledge of governing standards and regulations (e.g., 21CFR Part 4, Part 11, Parts 210/211, Part 820 QSR, ISO 13485, ISO 14971, Canadian MDR, EU Medical device Directive, JPAL)
• Regulatory inspection experience
• Knowledge of the contract manufacturing standards and experience working with contract manufacturers and suppliers
• Experience working with external contract manufacturing organizations
• Technical knowledge in Quality System elements, devices, design, manufacturing and commissioning and qualification

Other Information:

• Travel up to 25% related to contract manufacturing/supplier quality oversight activities; some international travel

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

$118,500 - $173,800

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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