QC Manager (FSP)

Job Nature & Scope:  

Key Working Relationships 

• Internal contacts within client

Global & Regional Team

• QA from R&D 

• Procedural & Process Management Network 

• Global LMS Administrator 

• Global PV enabling team 

Local Team

• Local Study Team Leaders and Local Study Team Members – Evidence Generation, China MA 

• GxP QMS, China MA 

• Head of Evidence Generation, China MA 

• Pharmacovigilance Personnel, China MA 

• Medical Excellence Manager, China MA 

• QC team member 

• External contacts with organizations outside client 

• Study team staff of Contract Research Organization  

• Study site staff 

Job requirements

Acts Decisively

• Makes Effective Decisions Under Pressure:  individual still makes effective decisions and can do so in the absence of complete information and when under pressure. 

Works Collaboratively

• Respects and Integrates Diverse Views: individual seeks input and demonstrates an appreciation for diverse views by incorporating them into decisions/ proposals. 

Results driven behavior 

• Always maintain a focus on the objectives and anticipated outcomes of the clinical trial, ensuring that all components are effectively advanced to meet the established goals.   

• Adapt work strategies and plans with flexibility in response to trial progress and feedback on outcomes. Enhance the trial process to improve both efficiency and quality.  

Establish robust alliances with both internal and external stakeholders 

• Establish and maintain close collaborative relationships with internal team members. Foster effective communication and collaboration among team members to facilitate the smooth progression of the trial.  

• Ensure consistent communication and coordination with external stakeholders.  

• Exhibit good teamwork and coordination skills in cross-departmental and inter-institutional collaborations.   

Self-motivation and adaptability 

• Demonstrate a sense of self-motivation, exhibiting the capacity to actively and enthusiastically engage in clinical trial work. Be able to devise effective solutions for the complex and dynamic situations in clinical trials.  

• Demonstrate a commitment to continuous learning and skill acquisition to adapt to the ever-evolving landscape of clinical trial regulations and technologies. 

Academic / Professional Qualification 

• Bachelor degree or above of medical/pharmaceutical background 

Working experience (No. of years / Job function / Business types)

Essential         

• At least 2 years working experience in clinical trial 

• At least 2 years quality management relevant experience 

• At least 1 year proven training or coaching experience  

Desirable  

• Procedural documents development experience  

• Clinical research experience within multinational pharmaceutical companies.

COMPETENCIES (Skill / Knowledge / Technical / Training requirements)

Skill

• Learning agility: swiftly acquire new knowledge and skills and apply effectively in practical works.  

• Presentation skills: confidently and fluently delivering training.  

Knowledge

• Experience of quality management in clinical trial 

• Excellent competence of GCP and clinical study procedure or pharmacovigilance 

Language ability

• Fluent oral and written English is essential. 

Computer literacy

• Proficient in the Microsoft Office software 

DUTIES & RESPONSIBILITES:

Study onsite and remote QC activities

• Conduct onsite QC and remote QC as per QC plan requirement.  

• Draft related QC Report within timeline and keep the quality observations be notified to CPM and QC head. 

• Provide suggestion of CAPA and have a follow up if needed. 

• Conduct TMF quality checks for studies with documentation as per QC plan. 

• Conduct study level QC if needed (e.g., safety handling QC, HGR QC, etc.) 

Training delivery/support

• Lead/support the NEO training  

• Deliver /support the routine training/on-demand training for EvGen teams which are to emphasize the procedural key points or the update of global/local procedures. 

• Organize learning from QC checking, Audit and inspection for study teams which is aimed at increasing study team capability for study delivery. 

Supporting Audits & Inspections readiness

• Manage and supports activities during the preparation/ongoing/follow up phase of an audit or inspection.  

• Support finding management in VQV, CAPA development and implementation. 

• Case Sharing of results and training of local project team, if required. 

Vendor Management

• Coordinator the Operational Due Diligence (ODD) activity.  

• Support the vendor ODD by third party and follow the CAPA implementation status if needed. 

• Conduct the periodic vendor performance assessment and follow up with related CAPAs. 

SUSAR Line Listing management

• Sampling check to ensure the accuracy of monthly SUSAR line listing translation from third party 

• Delivery the qualified monthly SUSAR line listing to the project team in time. 

Other

• Keep compliance with regulatory, industry, client standard/policy and SOP requirements. 

• Complete other tasks assigned by QC head.