Director, QA Data Governance, Biologics Manufacturing - Expat in South Korea

This is an exciting opportunity to lead and manage digital quality and data integrity compliance within a cutting-edge biologics manufacturing facility. You will be responsible for overseeing 2 functional teams for Digital QA and Document Management QA up to 30 team members. 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:

• Provide Oversight of the newly established Data Compliance group overseeing data integrity compliance efforts consistent with GMP and site Quality policies.
• Overseeing the DI framework and constituent policies, procedures, tools, and checklists governing DI and Computerized System Validation (CSV) that effectively establish data risk management stewardship and accountability throughout data and system life cycle (SLC).
• Lead Data Compliance QA, ensuring GMP and Quality policies are met.
• Ensure compliance with DI, ERES, and Computerized System regulations (US FDA 21 CFR Part 11, EMA EudraLex Vol.4 Annex 11).
• Execute DI training programs covering content, competency assessments, and compliance monitoring.
• Conduct DI audits and assessments for internal systems, vendors, and regulatory inspections.
• Improve technical DI controls, including audit trails, electronic signatures, and data validation checks.
• Lead system upgrades, change management, and automation improvements.
• Act as SME for IT and Data Integrity QA in regulatory inspections and audits.
• Oversee two sub-functions: Digital QA and Document Management Teams.

Desired Skills & Experience:

• BS or MS in Computer Science, Engineering, Information Technology, or a technology-related field.
• 8 years of experience working in an IT QA leadership role in Data Integrity or Computer Systems Validation within the BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industry.
• Regulatory compliance experience with CSV, CSA, and DI risk management.
• Expertise in Quality Management Systems, including Electronic Data Management Systems (EDMS), Electronic Quality Management Systems (EQMS), and Laboratory Information Management Systems (LIMS) such as Emerson, DeltaV, Waters, MasterControl or TrackWise.
• Expertise in GAMP, cGMP QA compliance, and regulatory audits.
• 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 - 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.

You can also view new photos of Korea and Songdo at https://www.linkedin.com/pulse/laguna-source-korea-2024-jeff-schwartzman-uvsyc