Manager, China Vaccines Clinical Quality
GSK
HuangPu District, Shanghai, China (Mainland),
5天前

Job Purpose

The incumbent will represent Vaccines Q4R&D locally in order to provide quality aversight of clinical development operations, clinical material (cold-chain) distribution and third party clinical labs in China, in interaction with global Q4R&D teams and in collaboration with TRD, CEG and GSK China teams (Regulatory, Medical affairs).

The network of third parties overseen should cover clinical material packaging and distribution (cold chain) service providers, clinical sites, clinical laboratories, including governmental laboratories, central laboratories, specialized laboratories and sample logistics laboratories.

Key Responsibilities :

  • Act as local relay for Quality for R&D related activities in China and build strong relationship with respective central Q4R&D experts
  • Support local third party selection / technical assessment process, led by business and central experts, and ensure vendor qualification is fulfilled with support of auditing function, where applicable.
  • Help unlock issues encountered in managing third parties.

  • Assess needs for Third Party Quality Oversight for the locally outsourced activities and ensures respective qualification measures are taken with support of Vx Quality auditing function where applicable
  • Provide management with elements required for management monitoring of outsourced activities. Interpret & communicate the quality / compliance performance of vendors, regarding GMP / GDP, GCP and GCLP regulated activities.
  • Delivers GCP and GCLP consultancy and ensures local training packages are aligned with R&D Vaccines’ training strategy and quality standards, in close collaboration with respective central Q4R&D experts.
  • Ensure clinical operations and clinical labs related audit and inspection awareness, coordinate internal audits, as well as Health Authority inspections, including NIFDC (governmental laboratories).
  • Act as first point of contact for local staff in GCP, GCLP, GMP (labeling, distribution and cold-chain) deviations or non-compliance issues identification and investigation.
  • Perform initial assessment and supports issue investigation and management of serious breach situations. Ensure cold chain excursions are promptly escalated to be managed by central team.

  • Ensure CAPA management at local level, facilitate CAPA implementation at third parties and provide regular status updates to local management and central functions.
  • Ensure smooth interface between TP laboratories and GSK stakeholders for quality & compliance matters.
  • Requirements :

  • Bachelor Degree / desired University Degree in the field of Biological, Bio-Chemical, Microbiology, Pharmacy, Clinical or other appropriate education and experience in pharmaceutical industry
  • Strong experience in managing clinical development activities and oversight of CRO laboratories, in the context of clinical and epidemiological studies
  • Knowledge of essential regulatory and industry guidelines both on local and international level, e.g. good knowledge of ICH GCP regulations, as well as GCLP.
  • Previous experience in quality assurance and risk management areas, including root cause analysis.
  • Sufficient knowledge of Vx product lifecycle
  • The incumbent must be fluent in Chinese and English
  • Strong interpersonal skills with sound cross-cultural awareness
  • Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible.

    Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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    GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses / agencies in respect of the vacancies posted on this site.

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