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.

Job Description

At Eli Lilly Cork, 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 41,000 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 patients around the world.

 

Eli Lilly Cork is made up of a talented diverse team of over 2,000 employees across 60 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!

Purpose:

The Sr. Director, Medicines Quality Organization – Cork is responsible for leading the MQO Cork team and ensuring quality management and oversight of Clinical Design, Delivery and Analytics (CDDA), Global Patient Safety (GPS), and Global Regulatory (GRA) activities. This role involves supervising, coaching, and developing MQO personnel, providing quality guidance and consultation to local and global business partners, and maintaining robust quality systems and compliance in Cork. The role also requires external focus on the regulatory environment to ensure ongoing compliance. The role works closely with but not limited to global MQO leaders, Global Quality Auditing and Compliance (GQAAC), legal, local leadership as well as local and global business partners across regulatory, safety and clinical.

Primary Responsibilities:

Leadership and Supervision

Partners with the MQO AVP/VPs to set the vision and strategic direction for Regional and Cork MQO and executes the vision and strategy effectively. Empowers team members to make decisions, resolve issues, and execute tasks at the appropriate level. Leads teams in the process of resolution of issues including resolution of conflict and building an environment focused on the expedited resolution of issues. Escalates issues and manages the interfaces to ensure issues are well researched, understood and resolved. Removes barriers to Cork MQO team success.

Coaching and Staff Development

Be responsible for coaching, assessing performance, facilitating career development, and resolving personnel matters. Develops, retains, engages, and plans succession for MQO Cork talent, and aligns with global MQO talent and development initiatives. Partner with Managers and assigned staff to effectively identify competency skills & behavior/performance gaps, provide ongoing coaching & feedback, support individual technical & professional growth, empower individuals to make logical decisions, lead the areas for which they have responsibility, resolve issues, and execute tasks.

Resource Management

Responsible for successfully allocating people & finances, to provide ongoing assessment of workloads, and to assure balanced & maximum efficiency of individual talent & capacity. Be an active participant in business planning ensuring the Quality needs for Clinical/Regulatory/Safety activities are fully represented.

Quality Compliance and Quality Expertise

Regulatory Monitoring and Compliance:

Participates in determining the impact of regulatory changes both locally and globally and disseminates information across assigned areas of responsibility. Provides guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level, ensuring compliance and inspection readiness. Provides key input into the design of the clinical, safety, and regulatory quality system and leads implementation into the business areas. Ensures on-going risk assessment and evaluation of quality of medical research, safety and regulatory operations to identify performance/compliance gaps relative to current regulations and company standards, guidelines and internal procedures and recommends robust corrective actions.

Quality Strategy and Quality Management in Medical, Regulatory and Safety business areas

Ensures the necessary processes are being effectively implemented to prepare for and manage regulatory inspections and responses to support the approval of regulatory submissions for our portfolio and to ensure pharmacovigilance activities compliance. Ensures appropriate and effective corrective and preventive actions are taken to address quality issues (noted from self-reporting/quality assessment/audit, etc.) Ensures that appropriate quality metrics/KPIs are maintained and evaluated for potential trends and improvement needs and communicates to senior management as appropriate. Ensures that MQO Cork personnel provide quality consultations/interpretation and define the quality direction to comply with external and internal expectations. Defines, implements, monitors, and manages the MQO related quality plan and reports on conformance to plan. Raises issues to senior leaders and business leaders as appropriate, including issues that may have the ability to impact the portfolio; uses root cause and analysis and other methods to develop well thought-out solutions and presents clear action plans.

Minimum Qualification Requirements:  

Bachelor’s degree in a clinical or scientific related fieldA minimum of 5 years of direct experience with GxP regulations, Quality System, Quality issue resolution, and regulatory inspections.A minimum of 8 years of experience in either clinical development, safety or regulatory functions.Demonstrated leadership at the director-level and above is strongly desired.Demonstrated decision-making skills.Demonstrated ability to operate across boundaries and influence others.Strong problem-solving and communication skills (written and verbal).Process improvement oriented.

Other Information/Additional Preferences:

Prefer Masters level or higher qualifications in clinical or scientific related field.Prefer experience across two of the functional areas of clinical development, safety or regulatory.This position is based in Cork, Ireland.Some travel will be required.

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.

Lilly does 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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