This is an exciting Expat opportunity to lead a newly established IT QA group within a cutting-edge biologics manufacturing facility.
As part of a leading Global Contract Manufacturing Organization (CMO), you will be responsible for overseeing the digitalization efforts and ensuring consistency with GMP and site Quality policies.
This is a once-in-a-lifetime Global Expat leadership opportunity in South Korea 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 :
- Establishing and training a new team on the requirements of Digital Quality systems and functions.
- Developing a framework for integrating QA oversight into routine business and operational processes within the organization.
- Leading involvement in change management, automation improvements, system upgrades, and establishment of routine processes (e.
g., audit trail reviews).
- Driving the implementation of Quality Management Systems and plant initiatives related to digital Quality.
- Serving as an IT QA Subject Matter Expert in regulatory inspections and audits.
- Ensuring compliance with relevant regulations and guidance for data integrity.
- Overseeing computer system validation processes and documentation.
- Developing and implementing SOPs and quality documentation within cGMP compliance.
Desired Skills & Experience :
- BS or MS in Computer Sciences, Engineering, Mathematics, or a technology-related field.
- At least 5 years of experience working in a similar leadership role in Automation / IT / QA / CSV within the BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industry.
- Experience working within a major Biologics CDMO / CMO environment.
- Deep knowledge and understanding of relevant regulations and guidance for data integrity.
- Familiarity with computer system validation processes and GAMP guidelines.
- Exceptional project management skills and experience working in multi-departmental teams or task forces.
- Expertise in Quality Management Systems, including Electronic Data Management Systems (EDMS), Electronic Quality Management Systems (EQMS), and Laboratory Information Management Systems (LIMS).
- Strong understanding of cGMP compliance and GMP documentation practices.
- Excellent communication and leadership skills.
Please Note - This is a full-time Expat Opportunity Based in South Korea. You must be open to living and working in South Korea.
A company paid apartment and International School tuition is provided.
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 - 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.
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