Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and relevant stakeholders (e.g. Clinical Operations, PV), and interacts with various teams to ensure corrective and preventative actions are taken to bring audit observations to closure as applicable. Activities may include routine and directed audits of investigator sites, vendors, regulatory documents and marketing applications, third party collaborations and due diligence activities.
Perform risk assessment and evaluate in area of responsibility.
Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk based QMS assessments and to support the implementation of associated risk mitigation strategies.
Supports the development of SOPs to ensure alignment with local laws and regulations.
Participates in the development/enhancement of QA procedures, guidance documents and audit tools.
Conduct the pre-qualificatioin audit to the potential vendors if required and provide the recommendations to the business for the vendor assessment and selection.
Provides input into Quality Agreement(s) signed with vendors as appropriate.
Actively involved/leading pre-inspection preparation activities in collaboration with business customers/partners.
Prepares and educates internal and external business customers/partners (incl investigator site staff) on inspection management.
Hosts and /or participates in inspection(s).
Responsible for inspection response management and tracking through resolution.
Actively participates in lessons learnt/shared learning.
To provide GCP and/or GVP compliance interpretation, consultation, training. Act as a subject matter expert to respond to GCP and/or GVP compliance inquiries.
Bachelor's Degree or equivalent in scientific or health related area.
A minimum of 8 years of previous Pharmaceutical Industry experience is required, with at least2~3 years of previous Quality related experience. Experience in conducting a broad range of audits is preferred.
Knowledge of ICH guidance, China local regulations, new drug regulations and current industry practice.
Knowledge of Quality Management Systems principles, including policies, procedures and processes.
Knowledge of clinical research operation and/or Pharmacovigilance and its QMS.
Proficient written and spoken English language skills.
Knowledge of drug development process.