GCP Quality Assurance Sr. Specialist at Global Biopharma

About Our Client

One of the top global biopharma companies in the industry
Rich pipeline from vaccines, oncology, immunology including track record of blockbuster products
Innovative and progressive therapies to meet unmet medical needs
Prides in supporting clients and patients focusing on various current events including the recent COVID-19 Pandemic

Prepare QA audits, generating reports, results in relation to QA management to the clinical trial team as well as other cross function departments
Ensure corrective and prevention to include GCP related audits for investigator sites, laboratories, regulatory documents, and market applications
Develop of QA procedures, guidance documents, and audit tools to standardisation of auditing approaches
Provide inspection management support on GCP issues and knowledge of proper SOPs, regulations for global and local rules
Provides training and mentorship for junior members in QA staff

In depth knowledge of GLP, GCP, GVP guidelines
Strong quality mindset including focus on details with standards
BS or BA degree in related scientific area with experience in the pharmaceutical industry including conducting broad range of audits
Knowledge with company systems, policies, and procedures for multiple therapeutic areas and nonclinical studies
High fluency in English and Japanese (non Japanese speakers will not be selected)