Associate Director – QA Parenteral Position Available In Durham, North Carolina

Job Description:

At Lilly, we unite caring with discovery to make life better forpeople around the world. We are a global healthcare leaderheadquartered in Indianapolis, Indiana. Our employees around theworld work to discover and bring life-changing medicines to thosewho need them, improve the understanding and management of disease,and give back to our communities through philanthropy andvolunteerism. We give our best effort to our work, and we putpeople first. We’re looking for people who are determined to makelife better for people around the world. Associate Director QualityAssurance (QA) Parenteral is responsible for the staffing,training, and leadership of the quality assurance group supportingthe project/expansion delivery, process development, operationalreadiness, start up, and validation/qualification of the parenteralprocess including dispensing, equipment preparation, formulation,filling and visual inspection. The Associate Director will helpbuild a strong quality culture and lead the QA team for oversightand support of the ongoing operation as well as site inspectionreadiness and execution.

Responsibilities:

Supporting the site toensure a safe work environment including supporting and leadingsafety efforts for team Build a diverse and capable siteorganization to support quality oversight, and ensure compliancewith area procedures and controls for parenteral operations Fostera strong quality culture including maintaining open communicationsand promoting teamwork and employee participation in the work groupDemonstrated administrative leadership of a diverse team includingperformance management and personnel development. Ability toutilize team through active engagement and delegation to achieveresults through others and deliver according to plan. Ability tomanage multiple priorities in a fast-paced environment and deliverin accordance with established due dates. Ability to demonstrateflexibility with quick response as priorities change or issuesarise. Support the development of the overall site operationalreadiness plan including establishment and reinforcement of qualityprocesses and approval of operational procedures Workcross-functionally with the area process teams/flow team formetrics reviews, operational support, and issue / deviationmanagement Review and approve GMP documentation includingqualification/validation protocols and reports, procedures,deviations, technical reports, change controls, etc. Partner withproduction and design organization to ensure 24/7 Quality oversightand support Engage and support Operational Excellence initiativesfor monitoring performance and continuously improving the operationNetwork with global and other parenteral network sites tounderstand best practices, share knowledge, and participate intactical and strategic business planning Support the Site QualityLeader in the development of the site organization, creation of theQuality Management System implementation plan, and execution ofsite quality operations in parenteral production Activecommunication on project and production status. Define, lead and/orsupport inspection readiness activities for operations and interactwith Regulatory agencies during inspections

Basic Requirements:

Bachelor’s degree in a science, engineering, computer,pharmaceutical related field of study or equivalent experience. 7years of experience in a Quality role supportingpharmaceutical/medical device manufacturing.

AdditionalSkills/Preferences:

Experience working in the pharmaceuticalindustry in QA/QC roles Previous experience in parenteralproduction support Previous management or leadership experienceincluding leading or working effectively with a cross functionalgroup Strong knowledge of Quality Management Systems and applicableregulatory requirements Previous experience directly supporting apharmaceutical manufacturing operation Excellent interpersonal,written, and oral communication skills Strong technical aptitudeand ability to train and mentor others Previous facility or areastart up experience Previous equipment qualification and processvalidation experience Previous experience with SAP or otherinventory management systems Previous experience with highlyautomated parenteral manufacturing processes including isolators,automated inspection, etc. Previous experience with ManufacturingExecution Systems and electronic batch release CQM, CQE, or CQAcertification from the American Society for Quality (ASQ) Previousexperience with deviation and change management systems including

Trackwise Additional Information:

Ability to work 8-hour days -Monday through Friday Ability to work overtime as required Abilityto travel up to 10% to Indianapolis, IN for meetings andcoordination with global regulatory organizations Lilly isdedicated to helping individuals with disabilities to activelyengage in the workforce, ensuring equal opportunities when vyingfor positions. If you require accommodation to submit a resume fora position at Lilly, please complete the accommodation request form( https://careers.lilly.com/us/en/workplace-accommodation ) forfurther assistance. Please note this is for individuals to requestan accommodation as part of the application process and any othercorrespondence will not receive a response. Lilly is proud to be anEEO Employer and does not discriminate on the basis of age, race,color, religion, gender identity, sex, gender expression, sexualorientation, genetic information, ancestry, national origin,protected veteran status, disability, or any other legallyprotected status. Our employee resource groups (ERGs) offer strongsupport networks for their members and are open to all employees.

Our current groups include: Africa, Middle East, Central AsiaNetwork, Black Employees at Lilly, Chinese Culture Network,Japanese International Leadership Network (JILN), Lilly IndiaNetwork, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQAllies), Veterans Leadership Network (VLN), Women’s Initiative forLeading at Lilly (WILL), enAble (for people with disabilities).Learn more about all of our groups. Actual compensation will dependon a candidate’s education, experience, skills, and geographiclocation. The anticipated wage for this position is $118,500 -$173,800 Full-time equivalent employees also will be eligible for acompany bonus (depending, in part, on company and individualperformance). In addition, Lilly offers a comprehensive benefitprogram to eligible employees, including eligibility to participatein a company-sponsored 401(k); pension; vacation benefits;eligibility for medical, dental, vision and prescription drugbenefits; flexible benefits (e.g., healthcare and/or dependent daycare flexible spending accounts); life insurance and deathbenefits; certain time off and leave of absence benefits; andwell-being benefits (e.g., employee assistance program, fitnessbenefits, and employee clubs and activities).Lilly reserves theright to amend, modify, or terminate its compensation and benefitprograms in its sole discretion and Lilly’s compensation practicesand guidelines will apply regarding the details of any promotion ortransfer of Lilly employees. WeAreLilly