[Janssen Vaccines] Head of QC
Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
1. 포지션: Head of QC
2. 계열사: 얀센백신 (Janssen Vaccines)
3. 근무지: 인천 송도
4. 근무 형태: Regular
The Quality Control (QC) Lead ensures that the site has robust, efficient, and safe laboratory operations that deliver high quality analytical/microbiology test results while maintaining and continuously improving compliance with applicable regulatory requirements. This includes the responsibility for testing of drug substance, bulk intermediates, raw materials, finished products, utilities and other support systems and any other samples needs to support the site and Janssen supply chain operations.
Ensure robust, efficient and safe laboratory operations that are compliant with cGMP and regulatory requirements of all markets to which the site supplies products.
Oversee investigations, CAPAs, and lab compliance for in-house and imported pharmaceutical products.
Develop an effectively functioning Quality Control (QC) teams with goals and
prioritization aligned with site quality and cross-functional leadership team and regional/global QC leadership team.
Lead people managers, guide career developments, conduct performance reviews, and establish training plans. Foster a collaborative team environment and high-performance culture.
Facilitate/support new product introductions, site/global projects, and continuous
improvement activities to reduce cost, improve quality and schedule adherence, and support site and global business strategies.
Develop operating budget for the laboratory consistent with the short and long-term business plan and monitor budget. Develop capital plan for laboratory equipment.
Identifies and reports adverse events and product complaints as per company procedures.
Review/approve QEM and change records
Attend QSMR, CPPM, and SQRR as lead of QC
Review/Approve Specifications and test methods
Review/Approve validation/Qualification Protocol/Report
Test Execution Management
n Review/Approve QC Test Order Delegated by Manufacturing Supervisor (Quality)
n Worksheet Issuance
n Review/Approve Release and Stability test results
n Make a QC Data Decision in eLIMS system
n Notify/Share test result with Stakeholders
Test Method Management
n Review/Approve Test Methods
n Review/Evaluate/Approve Compendial Test Method
n Review/Approve Analytical Method Transfer Protocol and Report
n Supervise QC Origination’s Data Integrity Program and Ensure that the data integrity requirements are fully implemented in the labs
General Lab Management
n Review/approve documents (Raw Data, Log Books, Calibrations, SOPs, Qualification/Validation protocol & Reports, etc.)
n Ensure that Lab equipment, instruments, Reagents and Materials are properly managed
Analyze Trends of Quality Issue to Improve Lab Compliance
Bachelor’s degree in Biology, Chemistry, Pharmacy, Microbiology or related scientific discipline with a minimum of 8 years of leadership/management experience in a GMP regulated QC laboratory
Leadership skills in coaching, development, decision-making, planning, and problem-solving. Focused on team success to meet the defined metrics and timelines.
Excellent interpersonal and communication skills (oral and written)
Fluency in English and Korean
Effectively applies scientific knowledge and interpretation of applicable regulatory requirements, industry standards, and pharmacopeia compendia (e.g., USP, EP, JP, etc.)
Expert understanding of new and emerging technologies for laboratory innovations.
Proficiency with computer systems (Microsoft Office applications, LIMS, Empower, etc.)
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