Johnson & Johnson Careers
Beijing-BQ-Senior Business Quality Manager
Requisition ID: 1805673023W
Regulatory Standards Management: The regulatory compliance representative is responsible to:
- Update the list of regulatory standards in the local quality manual.
- Monitor and evaluate regulatory standards to identify changes to existing standards listed in the local Quality Manual or new standards that could potentially impact the organization.
- Obtain information on changes from sources that include, but not limited to: Local country regulatory websites (for ex. Local HA websites); Johnson & Johnson Websites (for ex. Enterprise Regulatory Outreach); and from Professional organization websites and meetings.
- Identify business areas impacted by the proposed changes and disseminate new or revised regulatory standards information to the affected business areas to aggregates feedback from affected business areas SME’s and determine the organization impact of the changes, communicate the impact assessment to business unit management and stakeholders, including through Management Review.
- Ensure that the new or revised regulatory standards requirements are addressed by following the applicable business unit change control procedure and he/she ensures necessary compliance actions are properly documented.
- Monitor and ensure the appropriate implementation and follow-up of actions needed to comply with new regulatory standards through existing processes such as Quality Issue; Management Review and Internal audits.
- Provide process improvement proposal based on the changes of new local laws, regulations, standards, and guidance/guidelines.
Quality & System Elements: The regulatory compliance representative is responsible to:
- Drive maintenance and implementation of the Quality System via transposition of the applicable requirements (laws, regulations and the elements of the J&J quality policy, standards and procedures etc.) as are described in the BQM.
- Drive continuous improvement of the Quality System & processes using quality system performance information, in conjunction with information from periodic internal audits, deviation management, CAPA management etc.
- Drive strategic projects (e.g. ChP, GCE, etc.) 和 Regulation scan, GAP assessment, and drive mitigation plan define and execution
- Drives temporary/short term additional tasks as are assigned by the Quality Head, i.e. deployment of new quality IT tool or quality projects/ processes within the LOC
- Maintain an up to date list of all relevant product licences (marketing authorizations), relevant authorizations (e.g. manufacturing, packaging, importation, warehousing, distribution, testing, narcotics handling, etc.) per BQM
- Ensure that Xian Janssen products, packaging components, labelling meet the local regulatory requirements
- Prepare, update and approve LOC procedures in accordance with local GxP, BQ and J&J requirements
- Execute minimum requirements regarding lifecycle management of GxP related documents and records (creation, approval, distribution, revision, retrieval, retention, disposition) to ensure regulatory compliance and business continuity.
- Ensure appropriate internal and external change control systems are followed.
- Qualification and Training:
- Prepare, update, train and implement global BQ/local LOC procedures in accordance with local GxP, BQM and J&J requirements
- Inspection Management: Manage the preparation, execution and follow up for external inspections, and report these and any other relevant field action activity into Curve.
- Escalation of Quality and Regulatory Compliance issues:
- Notify and engage LOC Head of Business Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures outlined in BQM
- Education: Bachelor’s degree or higher in Pharmacy / Medicine or a related scientific discipline;
- Language: fluent Mandarin and English
- Experience in regulatory policy activities gained within China, region, national health authority, industry or trade associations
- Good working knowledge of the China regulatory framework and how that applies to pharmaceutical and healthcare product development
- Developed network amongst China regulators and other key associations and organizations.
- Knowledge of regulatory texts, legal texts and good experience of regulatory affairs.
- Up-to-date knowledge of relevant pharmaceutical legislation and GxP;
- Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners
- Knowledge and full understanding of the J&J Quality Policy (POL 001), and the procedures and processes outlined in BQ Manual
Xian-Janssen Pharmaceutical Ltd. (7043)