Commercial Quality Senior Specialist

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Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Beijing, China

Job Description:

Key responsibilities

 

MAH/DMAH System Management in Commercial Quality:

• Support to organize MAH composition board meetings and track follow up actions and archive the relevant meeting documents according to relevant requirements.

• Support to update and maintain living MAH/DMAH document in timely manner, e.g., framework, O chart, JD, delegation letter to reflect the latest process and requirements or due to newly published relevant regulations.

• Support to maintain the MAH related training process and training plan combining with QMS training and qualification system.

• Support to set up and maintain J&J Oversea MAH agreement as planned to ensure the compliance of regulatory requirements. Maintain good communication with overseas MAH composition board on DMAH Quality part update.

• Support to refine the MAH change / DMAH transfer / change process and support relevant MAH / DMAH transfer / change projects with collaboration of cross functional team.

• Support to build up and maintain the MAH digital tool with appropriate CSV completion according to SDLC process.

• Support to collaborate with HA (Health Authority) / industry to shape the regulatory environment for MAH/DMAH management in China.

• Support projects to ensure J&J China LOC MAH/DMAH system running smoothly and meet the regulatory and business requirements.

 

Product Management:

• Support for assigned product life cycle management including

• Complaint handling.

• New Product Launch and all other product portfolio lifecycle management processes.

• Regulatory Compliance:

• Ensure that J&J IM China marketed products, packaging components, labelling meet the local regulatory requirements.

• Support implementation of the regulatory standards management standard and procedures.

 

Other Quality & System Elements:

• Metrics, QSMR management and Quality planning:

• Support on Metrics Management and Quality System Management Reviews (QSMR) meetings on a timely basis and satisfy Johnson & Johnson (J&J) and regulatory requirements for both pharmaceutical and combination products following the Pharmaceutical Global Standard Operating Procedure (SOP) requirements.

• Following the Johnson & Johnson Quality Planning standard, lead to identify and communicate quality plan objectives aligned with applicable business strategies, regulations, and quality policy on an annual basis.

• Support for establishing, maintaining and implementation of Quality System as described in Quality Manual (QM). Prepare, update, train and implement global and Regional CQ / local LOC procedures in accordance with local GxP, CQ manual and J&J requirements.

• 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.

• Drives temporary / short term workforces as are assigned by the Quality Head.

• Support to ensure intra-company quality agreement (ICQA) update to date and be consistent with LOC related systems.

• Document and data management:

• During preparation and update of applicable LOC procedures, execute 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 related quality record retention according to J&J requirements.

• Responsible for assigned product change controls and ensure appropriate internal and external change control systems are followed.

• Events and Deviation Management:

• Ensure that all events and deviations for J&J China products and critical systems are timely handled, documented, investigated for route cause, and assessed for its impact on product quality and safety.

• Ensure appropriate corrective actions and preventive Actions (CAPA) are taken to mitigate the effect of an event/deviation as well as to prevent recurrence in the future.

• Training and qualification:

• Support to prepare, update, train and implement global CQ / local LOC procedures in accordance with local GxP, QM and J&J requirements.

• Support on MAH/DMAH related J&J China LOC training process and be responsible for the training activities in CQ and J&J China Commercial team regarding GxP trainings.

• Escalation of Quality and Regulatory Compliance issues:

• Support to notify and engage LOC line manager and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures outlined in QM.

• Inspection and audit management:

• Support the preparation, execution and follow-up for external inspections & internal audits.

• Conduct assigned (internal/self-) audits of GxP practices that are applicable for all regulated functions under J&J IM.

• Other works assigned by commercial quality leads.

Required Qualification and Core Competencies

 

• Minimally basic degrees shall be bachelor or above.

• Demonstrates strong written and verbal communication skills in both the local language and English.

• Expert knowledge of Microsoft software and presentation.

• Strategic thinking is required, with a focus on process improvement and optimization.

• Demonstrates strong pharmaceutical products and project management skills, with the ability to manage multiple tasks. Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes. Up-to-date knowledge of relevant pharmaceutical legislation and GxP.

•  ≥2 years' experience in the Pharmaceutical or related industry is preferred, ideally with a mix of Quality and Compliance (GxP), Distribution Warehouse management, Regulatory Affairs and some Sales & Marketing experiences. Quality and Compliance experience is essential.

Required Skills:

Preferred Skills:

Audit Management, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment

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