Senior Director, Global Process Owner – Quality Risk Management 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. About the job At Lilly, weunite caring with discovery to make life better for people aroundthe world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work todiscover and bring life-changing medicines to those who need them,improve the understanding and management of disease, and give backto our communities through philanthropy and volunteerism. We giveour best effort to our work, and we put people first. We’re lookingfor people who are determined to make life better for people aroundthe world. Responsibilities The Senior Director, Global ProcessOwner for Quality Risk Management, as a leader within the GlobalQuality Systems team, will establish and maintain the globalquality system for Quality Risk Management. They will providestrategic oversight and expertise for the global QRM process,including Global Quality System standards, practices, businessprocesses, implementation tools and associated IT systems.

Additionally, the Global Process Owner will lead the QRM Communityof Practice, including Global Process Leads and Area ProcessOwners. They will lead key global projects and priorities withinthe Quality System. The Global Process Owner will consult withLilly manufacturing facilities, external supplier organization,marketing affiliate quality operations, regulatory, research anddevelopment and other functions to educate on the quality system,and proactively ensure compliance of Lilly’s Quality Systems withvarious country agency standards, industry trends and scientificprinciples. Key Objectives/Deliverables The Senior Director, GlobalProcess Owner for Quality Risk Management is responsible to:

Establish and maintain the global quality system for QRM to drivestandardization globally. Own the Global Standards, Processes,Practices, Trainings, and implementation tools and ensure they aredesigned according to regulatory, industry and companyexpectations. Provide governance, lead the implementations ofimprovement initiatives and foster a robust compliance mindset.

Ensure processes are executed consistently across the organizationand monitor signals to drive continuous improvement. Act as theleader and SME to ensure supporting IT applications and analyticaltools are configured and maintained to support the business needsand facilitates accurate reporting and analytics. Define a commonset of global effectiveness and efficiency metrics to driveend-to-end performance. Monitor performance metrics, report andprovide insights to inform decision making to drive furtherimprovements. Develop, lead, mentor and maintain a community ofcross-functional SMEs to collaborate on proposed improvements anddeepen the knowledge of the associated processes & tools. Activelycollaborate with enterprise-wide teams on standardized globalbusiness processes. As the subject matter expert, ensure inspectionreadiness, directly interact with Health Authorities duringinspections and draft responses to observations as needed. Activelyengage in external organizations and industry organizations tomonitor policy changes for regulatory / external environments andadvocate / influence quality related policies and regulatoryrequirements related to Quality Risk Management. Own the globalrisk log and global risk register, ensuring that key quality risksacross the enterprise are actively being mitigated. Support theQuality Maturity Model initiatives by actively enhancing thecultural mindset across the enterprise to integrate QRM principlesinto routine processes.

Basic Requirements:

10 years’ experience inthe pharmaceutical industry in GxP roles, with several yearsQuality experience. Bachelor’s degree in Natural Science,Engineering, Pharmacy, or other Life Science-related field.

Additional Skills/Preferences:

Proven ability to work in a matrixedorganization with diverse teams and influencing areas not underdirect control. Strong strategic thinking capability with a focuson the ability to execute strategic decisions while balancingconflicting priorities. Proficiency in addressing operationalchallenges through structured approaches and innovative solutions.

Ability to drive process improvements and strategic decisions byanalyzing and interpreting complex data. Demonstrated changeagility in anticipating and leading others through change andambiguity. Excellent teamwork, interpersonal, and communicationskills, with the ability to communicate and collaborate at alllevels through various formats. Expertise in developing scalableand standardized processes across global operations to improveefficiency and reduce complexity. Demonstrated influentialleadership expertise and experience engaging with senior-levelfunctional leads. Strong leadership capability to make and act ondecisions while balancing speed, quality, and risk to delivervalue-added business results. Strong capabilities in establishinggovernance structures and proactively addressing quality andregulatory risks. Demonstrated people management experience.

Expertise in navigating and ensuring adherence to global regulatorystandards and frameworks. Prior experience with common QRM tools,how and when to apply them, and maintenance of a risk log or riskregister. Prior experience working in at least two of ClinicalOperations / Development, Pharmacovigilance, Product Research &Development or Commercial Manufacturing preferred.

AdditionalInformation:

Available to travel (domestic and international) whenrequired. Fluent in English, additional languages are alsorecommended. Role may be based at selected Lilly Locations inEurope or the US. Lilly is dedicated to helping individuals withdisabilities to actively engage in the workforce, ensuring equalopportunities when vying for positions. If you requireaccommodation to submit a resume for a position at Lilly, pleasecomplete 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 $151,500 -$222,200 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