Senior Manager, Quality Assurance APAC

5 days ago

Shanghai, Shanghai, China AstraZeneca Full time CN¥1,000,000 - CN¥1,200,000 per year

Summary Of The Role
As the independent second line assurance function for R&D, our mission in Quality Assurance is to achieve enduring excellence in auditing, quality management, quality risk assessment and enhance the R&D quality mindset for the benefit of our patients.

The Job Holder Is Responsible For

  • Planning, leading, conducts and reports audit activities for R&D GxP risk-based audit programs (GCP, GVP, GRP, Lab GCP, GLP)
  • Support of GxP inspection activities
  • Management of CAPAs related to audit and/or inspection findings in collaboration with QA colleagues and functions owning the issues.
  • Supporting the management of business relationships with defined stakeholder groups for quality strategic development and quality management activities for these stakeholders.

Role & Responsibilities
Audit

  • Plans, leads, conducts and reports audits in assigned GxP areas (GCP, GVP, GRP, Lab GCP, GLP), such as investigator site and/or project audits
  • Supports lead auditors in the planning, conduct and reporting of more complex audits such as Process / System, External supplier
  • Works with contract personnel or consultants to prepare, conduct and report outsourced audits

Inspection

  • Supports Quality Assurance team members, to manage and prepare for regulatory inspections

CAPA

  • Assesses need for, and assists in development of CAPA plans, approves and monitors plans to completion for assigned audits
  • Assists with the continuing follow-up of agreed audit CAPA actions from across QA to assist in the monitoring of QA Key Performance Indicators

General Accountabilities

  • Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines
  • Promotes a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
  • Communicates effectively with QA colleagues and business stakeholders
  • Maintains knowledge of relevant industry information affecting quality and compliance area
  • May provide responsive and proactive quality and compliance advice to defined customers.
  • Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
  • Travel expected

Requirements
Essential

  • Degree level education or equivalent experience in clinical development and quality management
  • Experience in pharmaceuticals or a related industry
  • Excellent analytical, written and oral communications skills
  • Fluent in written and spoken English
  • High ethical standards, trustworthy, operating with absolute discretion
  • Collaborative, influencing and interpersonal skills – curious to understand business environment
  • Skilled at managing & using technology
  • Ability to develop professional networks with stakeholders

Desirable

  • Audit Experience
  • Supplier qualification
  • Experience of regulatory health authority GxP Inspections

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