JANSSEN VACCINES] QUALITY ASSURANCE LEAD

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Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in pharmaceutical, medical devices and diagnostics markets, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.  Learn more at  https://www.
nj.
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1.
포지션.
Quality Assurance Lead 2.
계열사.
얀센백신 (Janssen Vaccines) 3.
근무지.
인천(송도) 4.
근무 형태.
Regular [Summary] Quality Assurance Lead manages other Managers, Supervisors, and/or individual contributors in support of the execution of processes and activities related to fulfilling the Quality Assurance requirements for the organization's products.
Ensures key quality deliverables are completed in accordance with required timelines.
Provides coaching and guidance to team in the identification of risks and development of mitigation plans, monitoring of data, and development of meaningful KPIs.
Is accountable for conducting effective performance management and establishes a culture of continuous improvement, growth, and development.
[Main responsibilities] Team Accountability The work scope of Quality Assurance is as followed.
   Establish/maintain QA programs, procedures including NC/Investigation, CAPA, Complaints, APR/PQR, Reject/Field actions and Release    Review and approval of Validation activities including process validation, cleaning validation and aseptic process simulation    Perform QA oversight and batch record review    Assure finished products are dispositioned per product specification and GMP requirement    Evaluate/approve nonconformances / OOS / CAPA / Change Controls per SOP    Reviews and approves reports and other documentation prepared by Development, Product, QA and QC for regulatory submissions and inspections   Organizational Leadership    Accountable for managing team in accordance with Site Quality priorities following the JSC Quality Business Cascade    Oversee delegation of tasks and projects to staff.
   Review progress reports and suggests resource allocation as necessary.
   Prepare and manage business unit budget.
   Manage team performance and succession planning through effective communication, coaching, training, and development.
   Evaluates performance and provides feedback.
Implements disciplinary actions, as necessary    Serve as a deputy for Site Quality Head   Responsibility of Manufacturing Supervisor (Quality) – Role defined by Korean Regulation Execute the tasks and job duties as Manufacturing Supervisor (Quality) per Korean regulation    Approver of MTO (Manufacturing & Technical Operations) & QA documents    Approver of QC (Laboratory) documents    Approver of Validation/Qualification documents    Approver of Quality Risk Management documents    Approver of documents related to APR/complaint/recall/audit & inspection    Approver of internal Audit monitoring plan and report    Approver of Stability & Monitoring documents    Approver of Change Control   Requirement    Minimum of bachelor’s degree in Life Sciences, Pharmacy, or Engineering discipline    Minimum 5 years in a leadership role within a global supply chain in Quality Operations or Manufacturing in the pharmaceutical or biotechnology industry    Strong understanding of parenteral manufacturing and knowledge of global regulatory requirements    Experienced in leading health authority inspections    Demonstrated leadership skill.
Ability to influence and negotiate across the organization at all levels    Ability to operate in a global matrix organization with multiple stakeholders    Strong decision making and problem-solving competencies    Excellent communication skills in Korean.
Fluency in verbal and written English    Strong foundation in risk management tools and experience in the development of proactive risk mitigation tools   [JD  확인 및 지원 방법] www.
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om -> Requisition number “W”검색 -> 해당 모집 공고 클릭 후, “Apply Now” [제출 서류] 영문 자유 양식의 이력서/경력기술서/자기소개서 [서류 마감일]  채용시 마감 [유의사항] - 국가보훈 대상자 및 장애인은 관련 서류 제출 시 관계 법령에 의거하여 우대합니다.
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