Associate Director - QA

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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Description:

The QA Assoc. Director is a partner with the Sr. Director, QA (in IAPI) in ensuring that operations in Global Facilities Management and Engineering Servicese (GFMES) and IAPI FUME/CS have robust quality oversight. The Assoc. Director is primarily responsible for the productivity and development of the QA employees, the quality of the product/results, oversight of operations and overall customer service. It is expected that the Assoc. Director will oversee the department’s performance, resolution of quality issues and regulatory compliance. The Assoc. Director also supports development of the business plan.

Responsibilities:

• Provide coaching/feedback to and develop QA employees; recruit new talent

• Utilize Human Resources tools to ensure that the right individuals are in the right job (e.g., Performance Management, Merit Delivery, Talent Assessment, Succession Planning and Staffing)

• Participate in GEM organizational planning and Quality Lead Team.

• Exhibit critical business decision-making ringing about successful results

• Provide input into the business plan and ensure conformance to department budget for areas of responsibility in GEM QA

• Exhibit cross-functional influence

• Take a leadership role in the implementation, maintenance and improvement of the quality systems

• Provide quality management oversight to the Corporate Standards Laboratory in alignment with Global Quality Standards and ISO 17025 accreditation requirements

• Approve deviations, procedures, protocols and change controls

• Develop and maintain processes that support inspections and audits; prepare individuals to interact with auditors and inspectors

• Participate in self assessments and regulatory agency inspections in GEM

• Ensure internal and external quality and supply commitments are met

• Provide quality management oversight for LTC Central Utilities, Manufacturing Engineering Services, the Corporate Standards Laboratory, IAPI Manufacturing (FUME), and CSQA activities for GEM and IAPI

• Manage the creation, revision and maintenance of cGMP documents (e.g., job aids, procedures, forms, etc) applying knowledge of quality principles and cGMPs

• Provide oversight and review of changes to the Global Quality Standards and ensure local implementation of changes

• Influence development of improved and streamlined quality systems

• Network with other sites regarding new or current quality systems, as well as to share best practices and knowledge

• Serve as a conduit for Corporate communications

• Communicate to and strive for integration of support groups outside of GEM

• Work closely with operational groups to ensure development of systems that will facilitate the workflow.

Basic Requirements:

• BS or equivalent in a scientific field or engineering

• Organization and prioritization of multiple tasks

• Demonstrated strong written and oral communication skills

• Demonstrated critical decision making, strong problem solving and analytical thinking skills

• Excellent interpersonal/people and networking skills

• Strong attention to detail

• Self-motivation

• Leading the way for ensuring a fair and equitable work environment

• Clear understanding of all cGMPs, policies, procedures and guidelines

• Ability to influence diverse groups

Additional Skills/Preferences:

• Experience in Production, Quality Control, Quality Assurance, Technical Services, Regulatory Affairs, Engineering or Administration is desirable

• Previous experience leading/mentoring people

• Understanding of statistical tools and analysis

Additional Information:

• Must complete Learning Plan for Assoc. Director

• No certifications required

• Tasks in GEM may include entering manufacturing and laboratory areas which require wearing appropriate Personal Protection Equipment (PPE)

• Must carry a mobile device to support 24 hour/day operations

• Travel outside of and within the US, usually 1 week or less, sometimes on short notice may be requested

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.

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