Senior Quality Manager, GxP Auditor

2 weeks ago

Manila, National Capital Region, Philippines George Clinical Full time
Senior Quality Manager, GxP Auditor - open to all Asian locationsHR Manager, East Asia at George Clinical

An opportunity has arisen for an experienced, adaptable and committed Senior Quality Manager/ GxP Auditor to join our dynamic team in any of the following locations - Hong Kong, Malaysia, Taiwan, Philippines or Singapore.

We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.

We are searching for individuals who are organized, results oriented and able to handle changing priorities. You will be willing to extend yourself and take on new challenges with a 'can do' attitude.

Who are we?

  • A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence
  • 20+ years of experience, 500+people managing 39+ geographical locations throughout the Asia-Pacific region, USA, and Europe
  • Full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration and post-marketing trial
  • We combine scientific leadership and global operational excellence, with strong experience in renal medicine, oncology, cardiovascular and chronic diseases to improve the health of millions worldwide.

Why work with us?

  • We are a global team, making a social impact
  • Competitive market salary and benefits
  • Flexible and agile working arrangements - onsite, hybrid or WFH (dependent on location)
  • Strong and diverse Learning & Development opportunities including exposure to scientific leadership
  • A focus on employee wellbeing including global employee engagement surveys, steps challenges, reward and recognition programs, team building activities and other fun events

About the role:

  • Implementing and supporting the Quality Management System in East Asia
  • Providing advice to stakeholders on SOPs, regulatory requirements and GCP standards
  • Supporting Operations Team to proactively assess risk and quality management cross the clinical trials
  • Contribute to review local CAPA, collate and analysis of quality metrics
  • Provide support to functional areas/project teams for hosting third party site audits, sponsor audits and inspections
  • Support and contribute to global SOP/WI management, also working with country leads and relevant FA authors to reflect local conditions and regulatory requirements as needed.
  • With guidance from Director, Audit Program, conduct investigational site audits to assess compliance with ICH GCP, local requirements, the relevant SOPs and defined project-specific quality and performance standards.

What are our expectations of candidates?

  • At least 3 years' experience in the quality assurance or quality management field for clinical research
  • Excellent knowledge and experience in planning, mitigating, and executing quality risk management across clinical research
  • Expert knowledge of ICH-GCP guidelines, global and local ethical and regulatory research requirements
  • Expert knowledge and experience regarding the conduct of compliance activities, site and process audits or reviews to meet GCP standards required
  • Ability to coach and mentor staff in relation to non-compliance and performance issues
  • Strong communication skills (written and verbal), including excellent presentation skills
  • Ability and willingness to travel.

We are searching for individuals who are excited by the idea of regional and global projects and teams, don't want to get lost in a large CRO and are ready to have their ideas heard

You will be willing to extend yourself and take on new challenges while living our values of Mutuality, Integrity, Can-do approach, Empowerment and Excellence.

How do I apply and what if I'm interested in a role in future or want to refer someone?

Apply via LinkedIn or send your CV, referral or confidential query to and our friendly HR team across the world will reach out as appropriate soon. Please provide your full contact details, the location you are applying for, whether you are interested in a current or future opportunity and we'll be in touch. We are reviewing applications as we receive them but please note that only short-listed applicants will be contacted.

How do I learn more about the roles and George Clinical?

Follow us on Linkedin to see our regular updates and how we celebrate our people and success across our business and projects You can also visit us at

We are reviewing applications as we receive them but please note that only short-listed applicants will be contacted.

Thank you for your interest in working with George Clinical. As a global business, we are committed to handling Personal Information in accordance with applicable privacy and data protection laws in the many countries in which we do business. Please see our Privacy Policy for further information.

Seniority level
  • Seniority level Mid-Senior level
Employment type
  • Employment type Full-time
Job function
  • Job function Quality Assurance
  • Industries Pharmaceutical na Pagmamanupaktura
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