Principal Associate - Quality Auditor (GQA) - Remote Singapore

About the role

Lilly is hiring a GCP Medical Auditor to work remotely in Singapore. The Quality Auditor belongs to the Global Quality Auditing (GQA) division and delivers quality assurance through internal and external audits supporting pharmaceutical development, non-clinical and clinical research, product commercialization, pharmacovigilance and consumer information quality. GQA ensures that GCP operations are performed in line with company standards, policies and procedures and with current regulatory requirements.

Key responsibilities

• Schedule, prepare, conduct and report GQA audits and assessments of GCP operations, internal and externally contracted, and escalate compliance issues
• Take part in or lead the risk assessment of GCP operations to build the GQA risk-based annual audit plan
• Help prepare and review standards, policies, procedures and guidelines, and prepare organizational metrics and audit finding trends when needed
• Advise GCP operations on the interpretation of corporate and regulatory GCP requirements
• Maintain strong communication skills with auditees, complete the Individual Training Plan and seek continuous self-development in GCP
• Participate in divisional improvement efforts such as Six Sigma projects and support training of other auditors

Required profile

• Bachelor's degree (or equivalent experience) in physical or biological sciences or another relevant technical area
• Minimum 5 years of relevant experience in GCP at Lilly or in the pharmaceutical environment, including working with third-party organizations
• Strong English speaking and writing; Japanese is an added advantage
• Domestic and international travel of up to 40% (1-2 weeks, sometimes on short notice)

Required skills

• Understanding of detailed scientific information and ability to interpret and apply regulations and regulatory guidance
• Experience with computers and entering data into databases
• Project management skills and ability to work independently and in a global team