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.
Purpose:
The purpose of the Medicines Quality Consultant (MQC) role is to support the development and implementation of quality systems strategy and activities to support Medicines Development Unit (MDU) and Lilly China Drug Development and Medical Affairs Center (LCDDMAC) goals and objectives for China. In support of this mission, the purpose of the role of MQC for the China affiliate is to act as a quality consultant and lead affiliate component functions together with management in integrating the quality requirements into the business processes. The MQC will implement the quality plan and ensure consistency between the global requirements and local requirements. This includes the implementation of Safety and Efficacy quality system and assuring that this system is aligned with appropriate quality and regulatory requirements. The MQC will provide updates on internal/external GxP trends and changes through applicable Local Leadership Forum and governance platforms. The MQC will act as a contact person regarding quality and business process compliance concerns between affiliates and global.
Primary Responsibilities:
Ensure local implementation of the Safety and Efficacy Quality System (SEQS)
- Review regional and/or local SOPs versus global policies, standards and procedures. Reviews SEQS documents and provides feedback
- Review or perform quality approval for local procedures, required tools, forms, templates
- Recommend new procedures or changes to existing procedures where applicable
- Provide quality oversight for compliance to SEQS
- Escalate compliance issues to management locally and globally as appropriate
- 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 contact person for global and affiliate
- Perform quality self-assessments
- Lead or facilitate GxP audits and inspections
- Coordinate audit and local regulatory responses including Trackwise system documentation
- Communicate and ensure inspection readiness requirements are in place; e.g. organization and availability of documents such as training records, job description, backroom and/or front room organization, etc.
- Educate affiliate employees for inspection readiness practices and inspection behaviors
Ensure the implementation and maintenance of affiliate Quality Plan
- Document the affiliate quality systems requirements ensuring clear accountabilities
- Manage or contribute to the affiliate quality plan
- Provide updates to quality and business owners
Implement and manage Quality Systems
- Monitor external regulatory landscape and lead internal efforts to conduct gap analysis. Communicates regulatory changes to global and local business partners.
- Provide consultation on the integration of quality into business processes
- Support the business on the application and facilitation of quality systems (deviations, notification to management, change control, etc.)
- Conduct root cause analysis and implement Corrective Action and Preventative Action (CAPA) process
**Drive trending of metrics to improve processes and compliance **
- Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions
- Monitor completion of deviations, CAPA related to deviations and change controls
- Monitor completion of audit responses through metrics
- Provide updates to management
- Share key learning to drive simplification and replicate best practices in the region and globally
- Coordinate quality improvement initiatives
- Seek and implement simplification and process improvement
- 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
Other responsibilities
- Understand the handling of confidential information (patient privacy, confidential audits and regulatory inspections)
- Understand the roles and responsibility of the EU Qualified Person for Pharmacovigilance (EU QPPV)
**Minimum Qualification Requirements: **
- Bachelors or Masters Degree in a science or health care related field, i.e., Pharmacist, Nurse, Biomedical Science
- Three years experience in quality and/or drug product safety/regulatory
- 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:
- 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 (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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