Compliance SpecialistⅠ/合规专员Ⅰ

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About the role

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. What You Will Achieve In this role, you will: • Be responsible for the application, maintenance, update and renewal of the site Drug Manufacturing License, organize relevant document preparation, internal review, system submission and regulatory communication, and ensure that changes to licensed items and registered items on the license are applied for and updated in a timely manner in accordance with regulatory requirements. • Be responsible for monitoring, identifying, interpreting and communicating laws, regulations, rules, the Chinese Pharmacopoeia and relevant guidelines issued by Chinese drug regulatory authorities; organize applicability assessments and gap analyses; drive and track the development and completion of remediation actions; and ensure that relevant regulatory requirements and national drug standards are effectively implemented at Wuxi site. • Act as Local Process Owner (LPO) for Pfizer Quality System processes in compliance area, support communication, assessment and implementation of quality system requirements at Wuxi site, and be responsible for local deployment and execution of relevant processes. • Support BoH GMP inspection-related activities, including inspection preparation, document coordination, on-site support, issue clarification, drafting inspection responses, cross-functional communication and follow-up of inspection-related actions, to ensure inspection management and subsequent remediation comply with Pfizer Quality System and regulatory requirements. • Act as site internal audit coordinator to coordinate the planning, preparation, execution, response drafting and follow-up action tracking of internal audits at Wuxi site, and drive cross-functional teams to complete assessment, responses and remediation actions for audit observations. • Be responsible for material supplier management to ensure supplier management complies with GMP and relevant regulatory requirements. • Assist Regulatory Affairs and China CMC team in new product registration, re-registration and post-approval change management, and support the preparation and review of relevant quality documents, site compliance information, license information and regulatory response materials. • Be responsible for Annual Product Reports(APRs) activities, including annual report planning, cross-functional information collection, document review, report preparation/submission coordination and follow-up of subsequent questions, to ensure annual drug reports are completed in a timely and accurate manner in accordance with regulatory requirements. • Be responsible for coordinating the implementation of quality management review at Wuxi site, including collection of review input materials, consolidation of quality metrics and trend information, meeting organization support, review outputs and follow-up of related actions. • Be responsible for site-wide communication, training and promotion of data integrity, and support data integrity risk identification, gap assessment, remediation action tracking and continuous maintenance of good data integrity culture. • Complete other related work assigned by Site Compliance Lead. Here Is What You Need (Minimum Requirements) • Bachelor’s

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