Job Description

Sr. Director/VP, Quality Assurance, Biologics Manufacturing, Expat Opportunity in South Korea

Direct message the job poster from Laguna Source

Recruiter/Managing Partner @ Laguna Source | 20+ years experience within Life Sciences, BioPharma & Food/Nutritional industries

This is an exciting Global Expatriate Executive leadership position responsible for overseeing strategic Quality Center operations within the World’s Largest biologics CMO with commercial monoclonal antibody, Antibody Drug Conjugate, and mRNA manufacturing capabilities.

This position oversees multiple Quality Center operations, Quality functions, and roadmaps including Quality Strategy & Implementation, Compliance and Risk Management, Client & Regulatory Relationships, and Quality Systems. It also offers a leadership opportunity to mentor and coach team members on Quality Systems and Compliance best practices. Your roles include:

• Leading a department of approximately 200 team members across various QA functions.
• Defining and implementing Quality Strategy & Compliance roadmaps.
• Ensuring product compliance with regulatory standards.
• Establishing and executing a Compliance Risk Management program.
• Supporting regulatory submissions and advising on regulatory pathways.
• Overseeing regulatory and client inspections.
• Developing quality and regulatory advocacy initiatives.
• Managing Quality Systems, ensuring they meet GAMP regulations.
• Coaching staff in deviation handling, root cause analysis, and change management.
• Managing the Quality organization’s budget and financial targets.

Desired Skills & Experience:

• BS, MS, or Ph.D. in relevant scientific or engineering fields.
• 20+ years in BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industries, with experience in large-scale biologics manufacturing.
• Leadership in Quality Assurance overseeing complex biologic modalities.
• Experience leading large, cross-functional teams with coaching and staff development skills.
• Significant leadership in Quality/Regulatory or Compliance, with CDMO experience highly regarded.
• Experience managing multiple Quality operations and organizational strategies.
• Global and cross-cultural working experience is highly valued.

Note: This is a full-time Expat opportunity based in South Korea. It includes a comprehensive benefits package such as a company-paid apartment, international school tuition, and relocation assistance.

Expatriate Benefits:

• Competitive salary, bonus, retirement allowance, and medical benefits.
• Luxury apartment in Songdo.
• International school tuition for children at Chadwick International School.
• Company-paid travel to the US or country of origin.
• Three weeks of vacation.
• Opportunity for career advancement within the world's largest biologics CMO.
• Work in a vibrant international community with US expatriates and access to travel opportunities.

Additional information and photos of Korea and Songdo can be viewed at this link .

Seniority level

• Executive

Employment type

• Full-time

Job function

• Quality Assurance, Manufacturing, and Research

Industries

• Biotechnology Research and Pharmaceutical Manufacturing

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