Sr. Manager – QA – Device Complaints

Industry:

Company: Eli Lilly and Company

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$91,500 – $134,200

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Indianapolis Device Manufacturing (IDM) Complaints Quality Assurance (QA) Organization is responsible for IDM’s Device and Drug/Device Combination Product complaint handling process. The Sr, Manager – QA Complaints main responsibilities include leading, developing, coaching and providing feedback to employees within the complaint lab. As well as performing human resources management for all direct reports.

Responsibilities:

• Ensure that adequately trained personnel and approved procedures are available locally and used for the completion of complaint investigations and associated activities.
• Effectively maintain and drive product and process improvements.
• Partner with area management to develop and maintain metrics to support the complaint investigation process.
• Effectively manage reviews and detailed investigations for complaints.
• Collaborate and provide customer service for groups external to the device organization. Participate in meetings with Affiliates, Global Patient Safety, Complaint Regional Centers, External Manufacturing, Material Suppliers, and Call Centers, as applicable, to share technical and complaint process knowledge and to support investigations as needed.
• Develop, improve and/or maintain new or existing QA complaint business processes. Proactively manage the team’s schedule and priorities.
• Provide project management leadership or support for site initiatives.
• Effectively maintain and improve Lean programs by ensuring completion of routine 5S checklists, the Complaints Lab Lean Huddle, and Leader Standard Work

Basic Qualifications:

• Bachelor’s Degree required. Degree in Engineering, Medical or Life Sciences field preferred.
• Minimum of three years’ experience in a regulated environment or manufacturing required.

Additional Skills/Preferences:

• Demonstrated leadership capability and good interpersonal skills
• Ability to coach and mentor
• Excellent written and oral communication skills including technical writing
• Ability to work across boundaries
• Technical skills and learning agility in the manufacturing or development of medical device/combination products
• Experience in drug delivery systems and technologies (e.g. pre-filled and reusable devices)
• Familiar with ISO 13485: Medical Devices – Quality Management Systems

Additional Information:

• Ability to handle returned complaint samples requiring execution of universal precautions and medical surveillance panel.

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 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.

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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