Principal Associate Global Medicines Quality Organization-China

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.

Implement and manage Quality Systems

Monitor external regulatory landscape and lead internal efforts to conduct gap analysis in the GxP areas (e.g. Good Clinical Practice, Good Pharmacovigilance Practice, etc.).

Contribute to external environment shaping by providing technical expertise in the GxP areas to strengthening Lilly Quality Management System and to make an impact on topics that matter to Lilly.

Communicates regulatory changes to global and local quality/business partners. Coordinate or lead Quality Management System improvements with global and affiliate functional areas to meet the requirements of international and local laws/regulations.

Provide consultation on the integration of quality into business processes.

Guide the business on the application of quality management system such as deviation, change control, and notification to management, etc.

Coordinate or conduct root cause analysis and guide functional areas to design and implement CAPA when applicable.

Manage or contribute to the affiliate risk assessment and quality plan.

Ensure local implementation of the Safety and Efficacy Quality System (SEQS)

Review released global policies, standards and procedures to ensure implementation in the affiliate.

Review or perform quality review for local procedures, required tools, forms, templates.

Recommend new procedures or changes to existing procedures where applicable.

Provide quality oversight for compliance to SEQS and local quality system elements.

Escalate compliance issues to management locally and globally as appropriate.

Plan and conduct risk-based quality oversight activities

Perform self-inspection based on the risk assessment.

Conduct quality oversight visit at clinical investigator sites when required.

Act as a quality consultant to identify, assess and mitigate potential risks with impact to GxP compliance, patient safety and data integrity.

Provide support for outsourced activities in alignment with internal standards.

Manage and support audit and inspection activities

Coordinate the interpretation about relevant regulations and guidelines and act as a Subject-Matter-Expert related to inspection management for global and affiliate.

Ensure inspection readiness processes and tools are in place to support internal and external partners.

Provide training to affiliate employees for inspection readiness practices and inspection behaviors.

Lead or facilitate GxP audits and regulatory inspections.

Coordinate audit and regulatory responses including documentation in the appropriate repository.

Drive trending of metrics to improve processes and compliance

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

Monitor completion of implementation actions as result of deviations, CAPA and change controls.

Monitor completion of audit and self-inspection responses through metrics.

Provide periodical inspection/quality metrics and recommendations to management.

Share key learnings to drive quality-by-design and process improvement in the affiliate and globally.

Coordinate quality improvement initiatives.

Other Responsibilities
Organize and support quality related training when required.

Lead or facilitate quality related topics at various affiliate communication platforms (e.g. leadership forum, governance meetings, employee training and workshops, etc.) to foster a quality culture

Understand the handling of confidential information (patient privacy, confidential audits and regulatory inspections)

Represent Lilly Quality on external engagement forums.

Minimum Qualification Requirements
Bachelor's degree in a science or health care related field, i.e., Pharmacist, Nurse, Biomedical Science

At least three years' experience in quality and/or relevant process improvement/quality control experience in drug development, safety and regulatory affairs

Demonstrated ability to interpret, implement and/or apply quality systems within a regulated work environment (GxPs, ICH, etc.)

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

Demonstrated ability to apply risk-based decision making in a regulated environment.

Proficiency in English (written and verbal)

Other Information/Additional Preferences
Master's degree or above degree is preferred

Relevant experience in clinical practice, clinical research and/or drug development process is value-added

Excellent communication (written and verbal), interpersonal, organizational and influence skills

Ability to travel

Demonstrated ability to work in a global environment and/or in a multi-national pharmaceutical organization

Demonstrated ability to prioritize and handle multiple concurrent tasks

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 ) 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.