Senior Director-Global Quality Systems-Quality

2 months ago

Indianapolis, United States Eli Lilly and Company Full time

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.

The Global Quality Systems Senior Director for Quality, as a leader in the Global Quality Systems team, will establish and maintain the quality systems for quality.  This includes Lilly Quality System and Global Quality System standards, practices, business processes and implementation tools. Additionally, the Senior Director will be expected to lead and manage key global projects and priorities within the Quality System. The Senior Director will consult with and educate on quality systems, and proactively ensure compliance of Lilly’s Quality Systems with various country agency standards, industry trends and scientific principles.

The position provides administrative management of quality systems associates and support staff in order to execute the establishment and maintenance of the Global Quality System. The position is responsible for a Global Quality System as a series owner and will have a team of direct reports that function as Global Quality Standard owners within that series.

This position plays a key role in the leadership of our global Quality Culture program and system ownership of selected global quality computer systems.

This position involves working with Lilly manufacturing facilities, Marketing Affiliate quality operations, and functions to assure that all aspects of the operation are in compliance with regulatory expectations and quality standards.

Key Objectives/Deliverables: 

·       Oversight of developing and maintaining Quality Standards.

·       Oversight of developing and maintaining global quality systems that govern GXP activity in manufacturing operations, providing education, training, and implementation tools to promote consistent processes.

·       Leading and/or supporting the assessment, development, and implementation of critical global projects in support of continual Quality System improvements.

·       Providing consulting support to site quality units and functions on interpretation and implementation of global quality systems.

·       Maintaining current awareness of current industry trends and regulatory agency interpretation of CGMP requirements, providing understanding of CGMP requirements and their application to manufacturing operations and influencing regulatory standards.

·       Develop performance plans and set objectives for quality system associates. Oversee daily work and provide direction as needed.

·       Influence internal and external environments with respect to issues pertaining to Quality System topics. 

Education:

  • BS, MS, or PhD in science, engineering, or related field.

    Basic Requirements:

    • Minimum 8 years direct experience in pharmaceutical manufacturing setting, including quality, operations, technical services, or engineering.
    • Strong knowledge of CGMP, GXPs, and quality systems with a minimum of 5 years of direct CGMP quality experience related to Manufacturing.
    • Proficiency in planning and carrying out tasks with a great degree of independence and as part of a team, with minimal supervision.
    • 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 customer needs and applying good problem-solving skills.
    • Previous quality system experience beneficial.

      Additional Skills/Preferences:

      • Ability to attend training courses, conferences, or association meetings to continue to gain knowledge in GXPs, to share such information with other members of the group or company to increase awareness and to train others in the implementation of these practices.

        Additional Information:

        • Must be available to travel (domestic and international) when required.
        • Requires visits to manufacturing/packaging sites globally.
        • Must be fluent in English, additional languages are also recommended.

          Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.

          #WeAreLilly

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