Sr.
Manager, Clinical Quality page is loaded
Sr.
Manager, Clinical QualityApply locations Ireland, Cork | time type Full time | posted on Posted Yesterday | job requisition id R-80534
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.
Eli Lilly Cork is made up of a talented diverse team of over 2,000 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking.
Inhouse People Development services, Educational Assistance, and our 'Live Your BEST Life' wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI).
We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network.
EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all.
Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself! The purpose of the Sr.
Manager, Global Medicines Quality Organization (GMQO) role is to maintain, develop, and improve quality system compliance and enhance quality by partnering with assigned portfolio/function(s).
This position is responsible for resource management, leadership, audit and inspection readiness, and quality project management and process improvement.
This position leads GMQO associates responsible for supporting the execution and delivery of submissions to global health authorities.
To achieve this goal, the role uses their technical expertise and a strong working knowledge of internal procedures and external regulations/expectations.
Primary ResponsibilitiesThis job description provides a general overview of the job requirements at the time it was prepared.
The job requirements of any position may change over time and may include additional responsibilities not specifically described here.
Please consult with your supervisor regarding your actual job responsibilities and any related duties.
1.
Leadership and Resource ManagementRecruit, develop, and retain a diverse and capable workforceEnsure robust training plans and timely completion of required training for direct reportsEnable talent identification and career development with an end-to-end mindset and sound judgmentEnsure GMQO associate competencies are present and continuously improvingManage workload based on portfolio priorities, regional requirements, and individual expertise, addressing resource management strategiesSupport and promote a culture of innovation and inclusivity to ensure diverse voices are heardCoach others in work procedures, the Safety and Efficacy Quality System (SEQS), and issue resolutionLead by example through credible technical coaching2.
Quality System ImplementationSupport, define, and facilitate quality reviews, consultations, deviation and change management, quality planning, CAPA, assessments, and issue resolution within your areaEnsure quality assessments monitor clinical development qualityReport metrics to managementSupport quality initiatives of business partnersRepresent Lilly in internal and external regulatory and safety quality areas3.
Audits and InspectionsFacilitate or deliver audits, inspections, and responsesMaintain ongoing inspection readinessEscalate issues impacting clinical activities and recommend follow-up actions4.
Project Management and Process ImprovementIdentify and drive projects for SEQS development and implementationSupport global process improvement initiativesShare learnings and best practices within and across teamsMinimum Qualification RequirementsBachelor's Degree, preferably in a health-related or scientific fieldExperience in clinical developmentSupervisory experienceExperience working globallyStrong leadership and self-management skillsExcellent verbal and written communication skillsKnowledge of GCP, GxPs, and relevant regulationsProblem solving and critical thinking skillsOther Information/PreferencesProject management experienceLilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities.
If you require accommodation to submit a resume, please complete the workplace accommodation request form.
Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, or other protected statuses.
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About UsAt Lilly, we strive to include, innovate, and deliver while maintaining integrity, excellence, and respect.
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