Supply Operation Quality Supervisor-Shanghai/Suzhou

Responsibilities

Assists with the timely implementation of applicable quality management systems (SOPs) within the PCO; Assists with ensuring initial and continuous training programs are implemented and maintained for all relevant PCO colleagues; Ensures planned, permanent & temporary changes of GMP/GDP related activities & systems are managed & documented appropriately; Ensures change actions are completed as per agreed timelines; Collects key quality performance indicators, evaluates and highlights any significant trends and identifies actions; Monitor Key Performance Indicators (KPIs) of the QMS, evaluate and highlight significant trends, and identify actions; Leads and/or participates in Quality Review Meetings as required; Provides support in the preparation and coordination of any Health Authority (HA) inspection and/or internal Pfizer audits of GMP/GDP activities in the PCO; Work with local cross functional team to define appropriate action plans to address the inspection/audit observation and tracks action implementation within the agreed timelines; Participates in the self-inspection program as an auditor and/or auditee, as required; Leads and/or participates in the Quality Risk Management program for the consistent application, documentation and communication of risks to product quality/patient safety in support of GxP activities under the remit of SOQ; Perform the local release process of Products under the PCOs distribution license, as required; Supports the coordination of all Product repackaging and/or relabeling activities in the PCO and at the third-party packaging site; Review and approve documentation related to the repackaging and/or relabeling of Pfizer Product, as required; Actions Quarantine Alert Notifications promptly, as needed; Ensures quarantine shipments are managed compliantly according to procedures, as required; Provides support for any market action operation in the PCO, as required; Complaint Handling – Perform Intake and Triage, issue correspondence letter as required; Acts as a contact point for Regulatory Agency/reporter in the PCO, as required; Lead and/or participate in deviation investigations using appropriate tools and works with cross-functional teams to implement CAPAs; Notify Management of significant concerns or deviations within the QMS which have the potential to impact product, regardless of release status; Where issues originate in the PCO, assist with the preparation of QRT meetings, where required; Assist with the implementation of local actions identified during QRT; Management of relevant corrective and preventative actions (CAPA); Execute tasks associated with the management of GxP Suppliers including qualification, quality oversight in accordance with internal and regulatory requirements for GxP activities; Assists with ensuring appropriate customer screening processes are in place to align with Pfizer and local regulations, as required; Assist with the coordination of RQA audits at the Supplier; Facilitate development and execution of objectives / projects consistent with SOQ Purpose Blueprint; Development and Maintenance of Quality culture, within the team and organization; Responsible for operation under GSP license; Responsible for IDC importation testing/surveillance testing; Responsible for Annual Product Report/Annual Product Quality Review Report completion as needed for regulation requirements; Support other required from local regulations

Requirements

A minimum Tertiary Education in Science, Pharmacy or related discipline; A minimum of 5 years in the pharmaceutical industry in a quality role; Demonstrated ability to influence, when necessary, particularly with stakeholders and external parties; Experience in GSP and QMS; Technical writing and reporting; Fluent in English (written & verbal)

Nice to have

Licensed Pharmacist is preferred; Experience in quality administered systems; Strong organizational skills and attention to detail; Experience with regulatory compliance and documentation; Ability to mentor and review the work of other colleagues; Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity; Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use