Medicines Quality对标SM/AD招聘-某医药公司-医脉同道

Medicines Quality对标SM/AD

38-92K/月上海市-上海/本科及以上/5-10年

杜震宇一周前来过

北京智天下科技有限责任公司

职位详情

岗位职责

任职要求：
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
岗位职责：
Senior Associate, Principal Associate or Sr. Principal Associate
Medicines Quality Organization (MQO) - CHINA
Purpose:
The purpose of the Senior Associate, Principal Associate or Sr. Principal Associate - Medicines Quality Consultant (MQC) role is to support the development and implementation of quality systems strategy and activities to support 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 functions and management in integrating quality requirements into business processes. The MQC will implement the quality plan and ensure consistency between the global 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:
1.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.).
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.
2.Ensure local implementation of the Safety and Efficacy Quality System (SEQS)
Review affiliate SOPs versus global policies, standards and procedures. Reviews SEQS documents and provides feedback.
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.
Provide support for outsourced activities in alignment with internal standards.
3.Plan and conduct risk-based quality oversight activities
Perform process 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.
4.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 Trackwise system documentation.
5.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.
6.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.