[얀센백신] Quality Assurance Lead

At Johnson & Johnson, we believe health is everything. 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.jnj.com/ .

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.careers.jnj.com -> Requisition number “2406178623W”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.

- 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연될 수 있습니다.

- 입사 지원 서류에 허위 사실이 발견될 경우, 채용 확정 이후라도 채용이 취소될 수 있으며 향후 채용이 제한됩니다.

- 제출된 서류는 반환되지 않으며, 별도 요청 시 삭제합니다.

www.careers.jnj.com