Associate Director Quality Packaging

Location: Indianapolis

Associate Director Quality Packaging page is loaded## Associate Director Quality Packaging locations:
US, Indianapolis INtime type:
Full time posted on:
Posted Todayjob requisition :
R-101434

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…