This is an exciting opportunity to direct, manage, plan, and perform internal audits including operational and compliance audits. This is a once-in-a-lifetime Global Expat leadership opportunity within the World’s Largest biologics CMO expanding to 720 KL total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. Your roles and responsibility will include:
- Lead Audits: Serve as the lead auditor for internal audits, ensuring timely escalation of critical findings.
- Report Findings: Provide reports of audit findings, analysis and recommendation to Quality Senior Management in a timely manner in order to strengthen and improve internal control, equity, and operational performance.
- Stakeholder Engagement: Collaborate with auditees to enhance internal controls and operational efficiency.
- Audit Schedule Management: Maintain and update the annual internal audit schedules.
- Report Preparation: Prepare detailed audit reports and review audit responses.
- Continuous Improvement: Support management in continuous improvement initiatives.
- Regulatory Monitoring: Keep abreast of regulatory regulations and present updates to GMP Auditing to ensure departmental compliance.
- Inspection Support: Provide support during health authority inspections.
- Auditor Training: Conduct auditor training and certification programs.
- Electronic Systems: Utilize and update audit-related documents in the electronic inspection system.
Desired Skills & Experience:
- BS, MS, or Ph.D. in Biology, Biochemistry, Chemistry, Molecular Biology, or related Scientific field.
- 10+ years of Quality and GMP experience in the BioPharmaceutical industry, with at least 3 years of GMP auditing experience.
- Knowledge of Data Integrity investigation and Data Flow and Data Criticality across the product lifecycle.
- Knowledge of Data Flow and Data Criticality of regulated activities across product lifecycle.
- Comprehensive understanding of ICH, FDA, and EMA GMP requirements, regulatory guidelines, and industry standards.
- Expertise in Quality Management Systems, including Electronic Data Management Systems (EDMS), Electronic Quality Management Systems (EQMS), and Laboratory Information Management Systems (LIMS).
- Excellent communication and leadership skills.
Expatriate Benefits Package:
* Competitive base salary, target bonus, retirement allowance and excellent medical benefits.
* Company paid luxury apartment in Songdo.
* International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools.
* Company paid airfares to visit the US (or country of origin).
* 3 weeks of vacation time.
* Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels
* Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University.
* Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport.
