Sr. Manager, Clinical Quality page is loaded
Sr. Manager, Clinical Quality
Apply 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 Responsibilities
This 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 Management
* Recruit, develop, and retain a diverse and capable workforce
* Ensure robust training plans and timely completion of required training for direct reports
* Enable talent identification and career development with an end-to-end mindset and sound judgment
* Ensure GMQO associate competencies are present and continuously improving
* Manage workload based on portfolio priorities, regional requirements, and individual expertise, addressing resource management strategies
* Support and promote a culture of innovation and inclusivity to ensure diverse voices are heard
* Coach others in work procedures, the Safety and Efficacy Quality System (SEQS), and issue resolution
* Lead by example through credible technical coaching
2. Quality System Implementation
* Support, define, and facilitate quality reviews, consultations, deviation and change management, quality planning, CAPA, assessments, and issue resolution within your area
* Ensure quality assessments monitor clinical development quality
* Report metrics to management
* Support quality initiatives of business partners
* Represent Lilly in internal and external regulatory and safety quality areas
3. Audits and Inspections
* Facilitate or deliver audits, inspections, and responses
* Maintain ongoing inspection readiness
* Escalate issues impacting clinical activities and recommend follow-up actions
4. Project Management and Process Improvement
* Identify and drive projects for SEQS development and implementation
* Support global process improvement initiatives
* Share learnings and best practices within and across teams
Minimum Qualification Requirements
* Bachelor’s Degree, preferably in a health-related or scientific field
* Experience in clinical development
* Supervisory experience
* Experience working globally
* Strong leadership and self-management skills
* Excellent verbal and written communication skills
* Knowledge of GCP, GxPs, and relevant regulations
* Problem solving and critical thinking skills
Other Information/Preferences
* Project management experience
Lilly 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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