PAt 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.brstrongPosition Brand Descriptionbr/strongThe Assoc. Director – GQAAC GMP Pharmaceutical role is part of the Global Quality Auditing and Compliance (GQAAC) division and represents the Global Quality Auditing interface for the commercial manufacturing organization. The position assures that an effective audit program is maintained that monitors global Lilly operations and Contract Manufacturers. It ensures that operations are performed in accordance with company standards, policies, practices and procedures and are compliant with current regulations and guidelines. This position involves supervision of an auditing staff that audits Lilly operations, both internally and externally (contracted), in support of the GQA Audit Strategy and in performance of Quality Due Diligence.brGQAAC is a valued business partner and takes a proactive approach to further enhancing the quality of business operations and regulatory compliance. The Assoc. Director – GQAAC GMP Pharmaceutical plays a key part in contributing to the implementation of this strategic approach to quality auditing and oversight within Lilly.brstrongKey Objectives/Deliverablesbr/strong /pulliTeam Management /liliProvide leadership and supervision to auditing team /liliEnsure that staff receives appropriate training and is aligned at appropriate staffing level /liliEnsure development of employee skills and knowledge to allow proficient execution of responsibilities. /liliWork with management team to set departmental strategy and objectives. /liliEnsure all direct reporting employees have a performance management and development plan in place and carry out their objectives and responsibilities. /liliBusiness/Strategic Leadership/Auditing /liliWork with management team to develop audit plan for auditable units within area of responsibility that aligns with the overall departmental audit plan for the corporation /liliEnsure audit processes are robust and ensure qualified personnel are assigned to product/project support and audit teams; direct resources in the execution of audit plan /liliEnsure consistency between audits /liliReview and approve audit and assessment reports and summaries in alignment with expectations /liliPerform site audits /liliDevelop with management team, communications on audit findings to senior management /liliEscalate any significant compliance issues to relevant site, development and quality management /liliStandards /liliReview and provide input to departmental corporate standards, policies and procedures /liliEnsure consistency of content of standards with requirements /liliPersonal Development and Shared Learning /liliAttend training courses, conferences or association meetings to continue to gain knowledge; share such information with other members of the team or company to increase awareness and to train others in the implementation of these practices /liliBe continually aware of current industry trends and regulatory agency interpretation of GMP and other relevant requirements /liliContinue to gain knowledge necessary to provide a greater understanding of GMP requirements /liliDivisional/Global Quality Organization Support /liliParticipate in projects as directed by Sr. Director, Global Quality Auditing Compliance that support or enhance GMP compliance of larger quality organization’s ability to carry out mission and meet objectives /liliParticipate in global projects/work groups as representative of GQAACbrbr/li /ulstrongMinimum Requirementsbr/strongulliMinimum Bachelor’s Degree in Pharmacy, Chemistry, Biology, Engineering, Microbiology, or other technical areas of study /liliMinimum of 10 years relevant industry experience in areas that must include: quality assurance or quality controlbrbr/li /ulstrongAdditional Preferencesbr/strongulliExperience in development operations, manufacturing operations or technical services in addition to quality is preferred /liliDemonstrated ability to communicate and deliver constructive feedback to customers, including excellent oral and written communication and oral presentation skills /liliDemonstrated ability to interpret and apply standards to different situations by understanding customer needs and applying good problem-solving skills /liliAbility to work independently and as part of a team with minimal supervision /liliTravel /liliPrevious auditing experiencebrbr/li /ulstrongOther Informationbr/strongulliMust be able to work in a manufacturing environment /liliIndividual must not be sensitive to penicillin/cephalosporin /liliMust be able to travel 25-35% including international travelbrbr/li /ulLilly 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 ( 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.brLilly 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.br#WeAreLillyUKandIreland #J-18808-Ljbffr