Associate Director Quality Packaging

Lilly • Indianapolis, IN

13h • Onsite

About The Position

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 .

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
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

• 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

Responsibilities

• 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.
• 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.
• 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
• 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.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level