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Purpose:
The purpose of the China Affiliate Quality Assurance – Quality Assurance Beijing role is to ensure compliance with cGxP standards and Domestic Responsible Entity (DRE) requirements for Lilly Beijing, while driving continuous improvement within Lilly China’s Quality Organization. The role concentrates on DRE-related activities in Beijing, including direct engagement with local regulators (e.g., Beijing MPA), inspection readiness, and monitoring regulatory changes. As the strategic front-line representative to regulators, it requires strong technical expertise, a broad understanding of company-wide quality governance, and the ability to integrate cross-functional inputs and communicate effectively.
It ensures local quality systems and procedures meet Chinese regulatory requirements, particularly those of the Beijing MPA. Close collaboration with the Shanghai Quality team and Suzhou GSP team is essential for post-market activities such as traceability, recalls, and complaint handling, etc. Familiarity with company functions and operational processes is critical for effective regulatory communication and inspection readiness.
Primary Responsibilities:
Beijing DRE Quality and Intelligence
Ensure authorizations from global MAH to local DRE are obtained and accurately maintained in the Beijing DRE quality tracking system, in collaboration with Legal, Patient Safety, and Regulatory Affairs.
Keep all DRE filing materials (e.g., contact details, organizational charts) updated and provide them to Regulatory Affairs for system submission, working closely with Quality teams and HR.
Maintain strong connections with RA, PS, SC, GA, Legal, LTC QA, and GMQO-China to address DRE compliance, commercial quality activities, and regulatory developments.
Manage quality agreements between China entities and global MAHs, ensuring compliance with MAH/DRE regulations and Lilly Global Quality Standards.
Liaise with local/global quality SMEs on regulatory updates (e.g., new or draft regulations), consolidate global feedback, and support submission to authorities or industry associations.
Collaborate with Shanghai Quality and Suzhou GSP teams on post-market activities such as traceability, recalls, and complaint handling, ensuring alignment with Beijing regulatory expectations.
Travel regularly to Shanghai to strengthen collaboration and understanding of workflows and processes.
Act as a bridge between regulators and internal teams, translating requirements into actionable processes and ensuring consistency across the organization.
Demonstrate strong communication and influencing skills to foster collaboration across RA, PS, SC, GA, Legal, HR, and global quality functions.
Quality Systems Compliance and Intelligence (DRE Compliance focus)
Ensure compliance with China MAH/DRE regulations across all GxP organizations, with a focus on Beijing requirements.
Establish and maintain a governance model for DRE responsibilities within the Beijing entity.
Act as the primary liaison with Beijing regulators, ensuring timely communication, documentation, and follow-up.
Implement robust monitoring and regulatory surveillance processes focused on Beijing, including tracking regulatory trends, inspection plans, and authority requirements. Consolidate feedback with local/global quality SMEs.
Maintain key quality processes and documents, such as the Affiliate Quality Manual, DRE Obligation Implementation Manual, gap assessments, and inspection readiness.
Coordinate and lead gap assessments against Lilly Global Quality Standards and GxP regulations (DAL, DALIR, DRE, etc.).
Participate in quarterly affiliate quality governance meetings (QLT), ensuring Beijing DRE topics are addressed.
Manage the affiliate Quality Annual Management Review for Beijing DRE, including timely deliverables, content preparation, and final review for approval by Lilly China and/or global management.
Ensure integration and consistency of quality system elements across all GxP areas (GMP, GDP) where possible.
Own change control and deviation processes related to Beijing DRE compliance and maintain robust CAPA tracking.
Collaborate with quality system and compliance teams to maintain overall affiliate compliance status and drive best practices and continuous improvement.
Lead or manage compliance and continuous improvement projects for the China Quality Organization.
Work with the affiliate Quality Compliance leader to define, develop, and monitor quality system elements, procedures, and personnel qualifications to fulfill DRE responsibilities.
Quality Self-inspection, Assessment and Audit Support
Play a key role in affiliate and Beijing DRE self-inspections, providing insights and recommendations to drive continuous quality improvement.
Conduct annual risk assessments and develop the Affiliate Annual Self-Inspection (SI) plan for compliance-related activities.
Perform quality assessments/audits of affiliate programs and third-party organizations (TPOs), including marketing or commercial programs, requiring knowledge of GMP, GSP, and MAH responsibilities.
Collaborate with local/global quality SMEs (e.g., IDM QA, GQAAC, local quality teams) to ensure effective self-inspections, assessments, and audits.
Internal Audit and Regulatory Inspection Readiness, and Regulatory Interactions
Lead and coordinate preparation for Beijing regulatory inspections, ensuring collaboration and clear communication with cross-functional teams; may include CFDI overseas inspections.
Act as the primary contact during Beijing inspections, managing regulator interactions and maintaining strong relationships.
Support readiness for Lilly internal audits conducted by GQAAC.
Partner with Quality and Business management to maintain a continuous state of audit and inspection readiness.
Work with the affiliate Quality Compliance leader to develop and execute inspection readiness (IR) and inspection support (IS) plans for GxP regulatory inspections and corporate audits, including preparation of local/global functions and TPOs.
Communicate with regulators during inspections in line with Lilly global standards and local procedures, ensuring proper interaction and strong connections.
Project management and Manufacturing GMP expertise
Support Lilly projects of expanding its commercial manufacturing capabilities in Beijing. Support Lilly global and local teams in the quality system capability building of GMP contract manufacturing organizations (CMOs), specifically solid dosage form manufacturers holding the “B certificate”.
Collaborate with global quality teams to ensure that China-specific regulatory requirements on contract manufacturing and MAH responsibilities are fully reflected in the local quality system design and implementation.
Engage with Beijing regulators to understand expectations, requirements, and inspection trends related to contract manufacturing quality management, and translate regulatory intelligence into actionable insights for internal teams.
Assist the Lilly contract manufacturing quality team in capability building, including virtual site establishment and the design of a robust quality oversight model, ensuring alignment with Lilly Global Quality Standards and China GMP obligations.
Act as a strategic facilitator and intelligence conduct, providing regulatory and compliance insights to internal stakeholders for effective execution, while not directly assuming the operational responsibilities of the contract manufacturing quality function.
Support Lilly teams to ensure that external manufacturing partners are prepared for inspections and audits, and that Lilly maintains strong oversight and governance of outsourced GMP activities.
Core Competencies
Strategic mindset and ability to integrate company-wide quality governance, regulatory expectations, and operational practices.
Strong communication and influencing skills to build trust with regulators and align diverse internal teams across Beijing, Shanghai, Suzhou, and global functions.
Proven experience in cross-functional collaboration with RA, PS, SC, GA, Legal, HR, and global quality teams.
Deep knowledge of China MAH/DRE regulations and inspection practices, with the ability to anticipate and respond to regulatory changes.
High adaptability and resilience, comfortable with regular travel, cross-site collaboration, and managing complex stakeholder expectations.
Minimum Qualification Requirements:
Bachelor’s degree in pharmaceutical science or related scientific fields.
At least five years of Quality Assurance experience in pharmaceutical GXP quality or GMP manufacturing, quality assurance or quality control (GMP knowledge and experience required).
Knowledge of China Regulations and GxP as well as the quality systems.
Demonstrated ability to communicate key strategic and technical information clearly and succinctly.
Capable of listening, speaking, and writing in English in fluency.
Other Information/Additional Preferences:
Strong GMP, GSP or commercial quality knowledge and experience in quality systems and development thereof.
Demonstrated project management skills.
Proactive coordination and communication skills.
Ability to effectively partner globally
Ability to navigate complex, matrix-based organizations
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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