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Purpose:

The purpose of the China Affiliate Quality Assurance - Quality Compliance (GMP focus) role is manage and lead operational, quality compliance, and continuous improvement activities for Lilly China Quality Organization to ensure cGxP compliance. This role has the particular focus on GMP related matters. The role is to ensure quality systems and written procedures are in compliance with GxP, Global Quality Standards, and China regulations and are followed in order to assure that all activities, programs, and processes related to products marketed in China are in compliance with applicable requirements.

Primary Responsibilities:

Quality System Compliance and Intelligence

Ensure local quality system management processes and procedures are in compliance with Lilly Global Quality Standards, and China laws and regulations including the requirements of Domestic Responsible Entity. 

Facilitate Drug Annual Report related processes and prepare quality information for the report annually. Ensure the compliance of the local Drug Annual Report process and the conduct of annual report by Domestic Responsible Entity, this may include the annual report preparation, consolidation, submission and relevant authorization within the company. Coordinate with cross-functional teams (Regulatory Affairs, Patient Safety, Supply Chain, etc.) to deliver the annual report. 

Lead/coordinate Drug Safety Incident Handling and associated training, drill exercise. 

Maintain critical quality processes and procedures including but not limited to GxP documentations, Change, Deviation and CAPA, Drug Annual Report, Self-Inspection, Quality Issue Strategy Team (IST) process and Drug Safety Incident Handling.

Lead/coordinate gap assessment of Lilly Global Quality Standards related with quality system elements (such as GxP documentation, Change, Deviation, CAPA, Self-Inspection, etc.) in a timely manner. 

Coordinate/Lead gap assessment of GxP regulations (e.g., DAL, DALIR, DRE, etc.) related with quality system/compliance activities in a timely manner. This requires collaborative work and influence of Lilly China cross-functional teams.

Ensure effective integration and consistency of quality system elements across all aspects of GxP (GMP, GDP, GVP, GCP) where possible.

Owner of the change control and deviation related with quality system/compliance activities and ensure all CAPAs have a robust tracking system. 

Co-work with team members of quality system and compliance to ensure the overall quality system compliance status of Lilly China affiliate quality are well maintained and always pursue for best practice and continuous improvement.

Lead and/or manage continuous improvement and compliance projects or activities for the China Quality Organization. 

Work with affiliate Quality Compliance leader to ensure compliance with China MAH/DRE regulations across all GxP organizations. This includes defining the quality system elements, development, maintenance and monitoring of the appropriate systems, procedures, capabilities, and associated personnel qualification to ensure the affiliate fulfils its DRE responsibilities. 

GMP focus Quality Intelligence

Have focus on GMP related regulations, guidelines which may have potential impact to Global quality standards or process at global manufacturing sites. 

Liaise with local/global quality SMEs on any GMP related China regulation update, such as newly promulgated regulations/guidelines, or draft for comment regulations/guidelines. Collect comments or feedback from global including some necessary discussion and supply back to local comment consolidation for submission to authority directly or to local Pharma industry associations. 

Maintain close connection with Suzhou site QA, RA for any GMP quality compliance related activities or matters, or any regulatory dynamics. 

Work with the Quality Compliance Leader to support any assigned task or initiatives in collaboration with local Pharma industry associations.

Stay abreast with GMP relevant regulatory dynamics, generate insights on the GMP compliance related to global MAH, ensure good connections, communications and collaborations between local DRE and global MAH for the GMP compliance maintenance for Lilly products marketed in China which are manufactured in overseas sites.

Device Specific Quality Support

Responsible for medical device involved in the programs and associated TPOs quality oversight and management of activities regarding production, quality complaint and investigation, etc.

Provide local QA device expertise for medical device related initiatives/projects at the affiliate. Work with affiliate Quality Compliance leader to liaise with global device QA SMEs and organizations to ensure appropriate compliance to, and oversight of, regulatory and Lilly device requirements.

Responsible for medical device related regulations assessment to see if any gap to local practice/process. Collaborate with global IDM to ensure appropriate documentations of assessment.

Quality Self-inspection, Assessment or Audit Support to affiliate quality activities, Marketing or Commercial programs and associated TPOs

Lead/coordinate affiliate and DRE quality self-inspection among Quality teams. Generate and provide quality insights and learnings from the self-inspection to affiliate quality management leaders regarding any efforts or need to drive quality continuous improvements. 

Conduct annual risk assessment and develop Affiliate Annual SI plan item for quality compliance related activities.

Perform quality assessment/audit to any affiliate quality programs and associated TPOs, this may include but not be limited to marketing or commercial programs. It may require knowledge of GMP, GSP, and/or overall MAH responsibilities for products of drug and medical device. 

Work with local/global quality SMEs to support good conduct of self-inspection, assessment or audit, such as IDM QA, GQAAC, local quality teams, etc. 

Internal Audit and Regulatory Inspection Readiness, and Regulatory Interactions

Lead/coordinate preparations and audit readiness work for the Lilly internal quality audit conducted by GQAAC. Ensure close collaboration and proper communication with cross-functional teams.

Support any regulation inspection preparation and readiness work. This may include overseas inspection by CFDI to overseas manufacturing sites and MAH.

Collaborate with Quality and Business management to ensure robust processes are in place to allow continuous state of audit and inspection readiness.

Support any sampling requirements from regulators for Lilly products and liaise with internal cross-functional teams in providing relevant materials. 

Work with the affiliate Quality Compliance leader to ensure successful GxP integrated regulatory inspections and corporate audits, including developing, communicating and executing inspection readiness (IR) and inspection support (IS) plans for inspections related to product imported in China.  This may include preparation of local functions and TPOs involved, as well as global functions and TPOs as appropriate based on the inspection.

Communicate with regulators as appropriate during any inspection as per Lilly global quality standards and local procedures, request by regulators. Manage the interactions properly and keep good connections with regulators.

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 production environment (including GMP knowledge and experience).  

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 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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