Job Title: Associate/Sr. Associate Medicines Quality Organisation
Job Description: We are looking for a talented professional to join our team in developing and implementing quality systems strategy and activities to support International Business Unit (IBU) goals and objectives for assigned countries or regions.
Key Responsibilities:
* Implement and manage quality systems
* Contribute to the development and review of country/region specific quality system documents to ensure requirements and accountabilities are represented
* Approve regional and/or local required tools, resources, forms, templates
* Assist in interpreting relevant regulations and guidelines and act as a contact person for global and affiliates
* Recommend new procedures or changes to existing procedures where applicable
* Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed
* Conduct root cause analysis and implement Corrective Action and Preventative Action (CAPA) process
* Support the business on the application and facilitation of quality systems (deviations, notification to management, change control)
* Support activities and processes related to external party management (such as, third-party organizations, business alliance partners) as assigned
* Perform quality self-assessments, as needed
* Provide Quality Oversight for business area(s)
* Monitor and provide quality oversight for compliance to Safety & Efficacy Quality System (SEQS)
* Communicates and escalates compliance issues to management locally and globally, as appropriate
* Provide consultation on the interpretation and practical application of external requirements, standards, and procedures
* Ensure implementation of regional and/or affiliate Quality Plan(s) as necessary
* Monitor progress of actions and provide updates to business and quality leadership
* Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions
* Monitor completion of quality related required actions such as: CAPA associated with deviations, change controls, audit or inspection commitments
* Provides input into risk assessments, audit planning and/or quality plans based on identified signal/risks/gaps
* Share key learning to drive simplification and replicate best practices in the region and globally
* C coordinate quality improvement initiatives
* Simplify and improve processes
* Audits and Inspections
* Facilitate audits/inspections (for example, preparation/readiness, coordination, back room, front room, responses)
* Manage audit and/or inspection responses
* Communicate and ensure inspection readiness requirements are in place, being organisation and availability of documents such as training records, job description, backroom and/or front room organisation
* Ensure completion of audit or inspection CAPA plans and timely resolution
* Partner 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
* Use a risk-based approach in guiding business areas
* Support key projects as assigned
* Understand the handling of confidential information (patient privacy, confidential audits and regulatory inspections)
* Understand the role and responsibility of the EU Qualified Person for Pharmacovigilance (EU QPPV) and as applicable, any locally required pharmacovigilance qualified person role
Required Skills and Qualifications:
* Bachelor's or Master's degree in a science or health care related field, Health care professional, such as: Pharmacist, Nurse
* Three years experience in quality and/or drug product safety/regulatory
* Demonstrated ability to implement, interpret and apply quality systems within a regulated work environment (such as GMP, GCP, GVP)
* Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies
* Demonstrated ability to communicate effectively, both written and verbal, and to influence others
* Demonstrated ability to prioritise and handle multiple concurrent tasks
* Demonstrated ability to apply risk-based decision making in a regulated environment
Benefits:
* We offer a premium workspace across our campus
* Flexible hybrid working options
* Healthcare, pension and life assurance benefits
* Subsidised canteen
* Onsite gym
* Travel subsidies
* On-site parking
* Inhouse People Development services
* Educational Assistance
* Live Your BEST Life wellbeing initiatives
Others:
* Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions
* 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