Hybrid Sr. Associate / Principal Associate - Global Medicines Quality Organisation – Global Regulatory Affairs en Lilly

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 2000 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 purpose of the Senior Associate/Principal Associate – Global Medicines Quality Organisation (GMQO) representative is to support the development and implementation of the strategy for quality systems and activities to support business goals and objectives. This includes execution of quality system deliverables to ensure compliance, quality oversight of business areas to integrate requirements, audit/inspection support and collaboration within quality and other areas.

This Quality role will support Global Regulatory Affairs (GRA). GRA develop and execute regulatory strategy, and lead interactions with Regulators. This includes monitoring changing legislation, submitting reports, summaries and labelling as part of marketing applications to regulatory agencies.

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. Implement and Manage Quality Systems

• Contribute to the development of GRA procedures and required tools, resource documents and supplemental materials, including review and content approval (as assigned) of quality system documents.

• Recommends new quality system documents or changes to existing quality system documents where applicable.

• Advise on appropriate training for implementation and documentation.

• Provide consultation on the interpretation and practical application of external requirements, standards, and procedures.

• Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed.

• Consult on root cause analysis and corrective/preventive actions (CAPA) including review/approval as necessary. 

• Provides input into risk assessments, audit planning and/or quality plans based on identified signal/risks/gaps.

• Complete self-inspections and drive improvements that are meaningful and actionable

• Ensure local implementation of the quality systems as necessary. 

• Provides support related to external party management (for example, third-party organizations, business alliance partners) as assigned.

2. Provide Quality Oversight for business area(s)

• Monitor for compliance to quality system documents.  Anticipates gaps and proactively proposes solutions.

• Communicates and escalates to management as appropriate.

• Ensure implementation of Quality Plan(s) as necessary. Monitor progress of actions.

• Provide updates to quality and business owners.

• Seek and implement simplification and process improvement.

• Coordinate quality improvement initiatives.

• Review metrics and trending to improve processes and compliance, as assigned.

  Compile compliance metrics and maintain metrics.

  Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions.

  Monitor completion of deviations, change controls, CAPA, audit responses.

3. Audits and Inspections

• Provide support for audits/inspections (for example, preparation/readiness, coordination, back room, front room, responses).

• Communicate and ensure inspection readiness (for example, organization and availability of documents such as training records, job descriptions)

• Ensure completion of audit corrective action plans and timely resolution.

• Leads and/or supports readiness activities in collaboration with business partners.

4. Partnership with other area(s)

• Functions as the initial point of consultation for business areas on quality related questions.

• Partners with the business area(s) to strengthen and ensure appropriate quality controls are in place.

• Shares key learning to drive simplification and replicate best practices.

• Collaborates with other quality groups as appropriate and develops quality network.

• Establishes good working relationships with assigned business area(s).

• Actively participates in team, business and quality related meetings.

• Supports issue resolution including escalation.

• Utilize a risk-based approach in guiding business areas.

• Support key projects as assigned.

• Serve as an IT systems business quality assurance (BQA) representative for IT systems, as assigned. 

  - Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures. 

  - Review and approve as appropriate, documents associated with the development and maintenance of IT systems as the representative of MQO, Regulatory Quality. 

  - Partner with IT and the business on system related initiatives/changes as the BQA for assigned IT systems. 

Minimum Qualification Requirements

• Bachelor’s Degree in a regulatory/science/health care related field or equivalent work experience.

• Demonstrated ability to apply quality systems within a regulated work environment.

• Effective project and time management skills.

• Demonstrated ability to communicate effectively, both written and verbal, and to influence others.

• Demonstrated ability to prioritize and handle multiple concurrent tasks.

• Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies.

• Strong interpersonal skills with demonstrated flexibility in varying environments/geographies.

• Effective organization/self-management skills.

Other Information/Additional Preferences

• Master’s degree or above.

• Five years’ experience or more in quality and/or drug product safety/regulatory.

• Experience in a quality control/quality assurance role.

• Ability to work independently and as part of a team.

• Demonstrated ability to work in a global environment.

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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