Associate Director Quality Packaging

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.

• by The Associate Director / Director is responsible for managing the activities of Quality Assurance personnel supporting Indianapolis Device Assembly and Packaging (IDAP), with respect to leading, facilitating, educating, enforcing, and ensuring compliance with current Good Manufacturing Practices (cGMPs), global standards, and site requirements. This role is also the key contact for internal and external inspection and maintaining the areas inspection readiness. They will also serve as a liaison between site lead team, process teams, flow teams, global and network forums focused on their area of responsibility .

Key Objectives:

1. Quality System: Ensure compliance with cGMPs and quality corporate policies with special attention to the following:

• Validation / Qualification: Participate in defining strategies and policies of validation / qualifications requirements. In addition, to ensure the implementation and execution with the established commitments for ensuring compliance with good manufacturing practices (GMP) or GxP.
• Change Control: Evaluate and approve the impact of proposed changes in the light of validated processes, regulations, and regulatory commitments.
• Deviations: Evaluate, assess, and approve the impact of deviations in the light of validated processes and regulations to ensure that the quality of the product is not affected. Ensuring the effective of corrective actions associated with action plans cover the root cause of the situation to eliminate them and has been evaluated with a holistic approach.
• Standard Operation Procedure (SOPs): Ensure that appropriate procedures are available to cover all activities related to Good Manufacturing Practices (GMPs / GxPs). Ensure staff affected have been properly trained in the content of the SOPs.
• Documentation: If required, write, publish and present regulatory changes and technical reports. Ensure compliance with records retention requirements and properly maintain them.

2. People:

• Education & Training: Ensure that members of the Quality Assurance unit meet their training plans, according to the position. Actively expand knowledge of technology, applicable regulations through external trainings, reading magazines, among others. Coaches, mentors, and enables knowledge transfer to direct reports, identified associates, peers, and leaders.
• Participate actively in the activities and meetings of the Quality Organization. Ensure that all Quality Assurance staff have assigned training plan according to their position and responsibilities. Ensure that there are job descriptions for all positions within their area of responsibility.
• Maintain the independence of the quality assurance issues and quality decisions, including management of QA resources.

3. Functional Responsibilities:

• Lead and actively participate in Quality lead team, applicable functional lead teams, and global / network governance meetings.
• Participate actively in the implementation of safety, quality, and lean initiatives.
• Understand processes under current responsibility ensuring knowledge of critical parameters, risk assessments, and area performance.
• Advance and align data integrity, technology enhancements, system upgrades, and process flows with global and network expectations

4. Management of Controlled Substances, if applicable:

• Comply with all established requirements to receive and maintain authorization to handle controlled substances.
• Successfully complete the background check process.
• Complete the training assigned to your learning plan within the established due dates.
• Report drug diversion.
• Report illicit activities by employees.

5. Minimum Requirements:

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
• Minimum 5 years’ experience in pharmaceutical/medical device industry including leading or working effectively with a cross-functional group
• Demonstrated problem-solving and decision-making skills

6. Additional Skills/Preferences:

• Strong knowledge of Quality Management Systems and applicable regulatory requirements 
• Previous regulatory inspection readiness and inspection execution experience
• Previous experience in Quality unit in pharmaceutical company
• Previous experience with deviation and change management systems
• 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

7. Other Information:

• Travel may be > 10%.
• On-site support is required and follows the work from home global manufacturing and quality policies.
• Overtime and responding operational or site support outside of core business hours and days is required.
• Applicant will work in various areas within the IDAP Plant. Some allergens are present in IDAP. Mobility requirements and exposure to allergens should be considered when applying for this position.
• May be subject to Post Offer Exam

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 - $180,400

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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