Sr. Manager, Clinical Quality

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 is intended to provide 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 in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

1. Leadership and Resource Management

- Recruit, develop, and retain a diverse and highly capable workforce

- Ensure robust individual training plans and timely completion of required training for direct reports

- Enable talent identification and career development that reflects an end-to-end mindset and demonstrates judgement-based decision making

- Ensure GMQO associate competencies are present and continuously improving

- Manage workload based on portfolio prioritization, regional requirements and individual level of expertise, and address implications to overall resource management and strategies

- Support and encourage a culture of innovation and model inclusivity to ensure diverse voices and ideas are heard and considered

- Coach others in the areas of 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/or facilitate quality reviews, quality consultations, deviation and change management, quality planning, CAPA implementation, quality assessments, quality issue resolution within area of responsibility

- Ensure quality assessments are conducted to monitor the quality of clinical development within the business area

- Monitor and report metrics to business management

- Evaluate and support quality initiatives of business partners

- Represent Lilly both internally and externally in the area of clinical development, regulatory or safety quality

3. Audits and Inspections

- Facilitate and/or deliver audits, regulatory inspections, and regulatory responses

- Ensure ongoing inspection readiness of area

- Escalate issues that will significantly impact clinical development activities, portfolio delivery, and business priorities, and recommend necessary follow-up actions

4. Project Management and Process Improvement

- Identifies and may drive projects for the development and implementation of the SEQS

- Supports global process improvement initiatives

- Share learning and ensure communication to share best practice within business area and across the Medicines Quality Organization

Minimum Qualification Requirements

- Bachelor's Degree, preferably in a health-related or scientific field

- Experience in clinical development

- Supervisory experience

- Experience working in a global environment

- Strong leadership and self-management skills

- Strong verbal and written communication skills

- Knowledge of GCP guidelines, GxPs, and regulations within the area of responsibility

- Demonstrated problem solving and critical thinking skills

Other Information/Additional Preferences

- Project management experience

Lilly 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 (https://careers.lilly.com/us/en/workplace-accommodation) 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.

Lillydoes 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.

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