- Contribute to the development of area specific procedures and required tools, resource documents and supplemental materials, including review and content approval (as assigned) of quality system documents. Ensures the regional and/or affiliate quality system requirements have clear accountabilities, as assigned.
- 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.
- Monitor for compliance to quality system documents. Anticipates gaps and proactively proposes solutions.
- Communicates and escalates to management as appropriate.
- Ensure implementation of regional and/or affiliate 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 process (for example, periodic report metrics).
- Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions (for example, PRAC assessment reports).
- Monitor completion of deviations, change controls, CAPA, audit responses
- 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.
- 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.
- Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV), if applicable.
- 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.
- Bachelor's Degree in a science/health care related field or equivalent work experience
- Demonstrated ability to apply quality systems within a regulated work environment
- Strong understanding of pharmacovigilance regulations and guidelines.
- Effective project and time management skills
- Knowledge of GCP, ICH, FDA, and other regulatory requirements
- 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
- Minimum of three years' experience in clinical trials and/or pharmacovigilance
- Proficiency in pharmacovigilance software and databases.
- Experience in a quality control/quality assurance role
- Experience in defined functional business areas, for example, safety management
- Knowledge of quality systems
- Ability to work independently and as part of a team
- Demonstrated ability to work in a global environment
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Associate / Sr. Associate - Medicines Quality Organization (Pharmacovigilance) - Cork, Ireland - Lilly
Description
We're looking for people who are determined to make life better for people around the world.
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 39,000 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 1,400 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.
Lilly 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.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself
Purpose
The purpose of the Associate/Senior Associate – MQO 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. Pharmacovigilance experience is essential to a successful candidate as they will be directly supporting the Safety Management group in Cork.
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.
Implement and Manage Quality Systems
Provide Quality Oversight for business area(s)
Audits and Inspections
Partnership with other area(s)
Minimum Qualification Requirements
Other Information/Additional Preferences
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.
#WeAreLilly
