Associate Director, Clinical Supply Planning and Delivery (CSD), Compliance Management

Associate Director, Clinical Supply Planning and Delivery (CSD), Compliance Management

Company Name:

Eli Lilly and Company

Found 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.

Purpose:

The CSD Compliance Management Associate Director provides critical oversight, leadership, and cross-functional integration to ensure that our processes and quality systems are efficient, effective and compliant. They consult with and educate customers on Deviation/Change Management as well as quality issues and proactively ensure compliance of Lilly’s Quality Systems and ensures the CSD function maintains the highest quality standards and complies with regulations and quality system requirements. Furthermore, this position is responsible for driving continuous improvement through effective responses to deviation investigations and oversight to change management. This position is responsible for developing and maturing our deviation and change management capabilities & processes.

Key Responsibilities

• Lead and drive the management of TrackWise Deviations across CSD while working with the Quality function to ensure alignment of resolution plan.
• Make complex technical decisions that help remove barriers for resolution (internal/external to the function) for Deviations/Change Controls.
• Work externally and cross functionally to understand best practices from a quality standpoint and implement changes where needed.
• Continually evaluate CSD state of compliance with Deviation Management and Change management – and influence senior management to drive improvement of potential issues while proactively providing a solution.
• Constantly evaluate departmental Deviation and Change Management capabilities to identify risks. Lead and evaluate TrackWise outputs, present possible trends to lead team while working with the process owner and/or end user groups to take appropriate actions.
• Leads and serves as primary author for Major Deviations, cross-functional/complex Change Controls (including company acquisitions).
• Leading and/or supporting the assessment, development and implementation of cross-functional projects in support of continuous Quality System improvements.
• Acting as the Subject Matter Expert and providing compliance oversight for cGMP’s and business requirements. The primary focus for this is on quality systems.
• Providing consulting support to CSD business and other business areas across PR&D (as needed) on interpretation and implementation of Deviation and Change Management systems.

Position Requirements

• 3-5 years of experience in related technical area (recognized as a technical expert)
• 1-2 years of significant TrackWise experience (i.e. system usage)
• Proven experience in working in regulated environment; strong working knowledge of cGMP and GCPs.
• Proficiency in planning and carrying out tasks with a great degree of independence and as part of a team, with minimal supervision.
• Proficiency in combining requirements and data from multiple and varied sources, reconciling differences and negotiating resolution to issues in order to develop or improve standards and supporting practices.
• Demonstrated ability to communicate and deliver constructive feedback to customers, including good oral, written and presentation communication skills.
• Demonstrated ability to interpret and apply standards to different situations by understanding both the standards and customer needs and by applying good problem-solving skills.
• Demonstrated ability to develop business presentations and effectively communicate the concepts to a multiple range of personnel.

Education:

Bachelor’s degree in a scientific or medical related field or equivalent work experience.

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 $111,000 - $162,800.

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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