[한국얀센] Business Quality Cluster Lead

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: Business Quality Cluster Lead 
2. 계열사: 한국얀센 (Janssen)
3. 근무지: 서울시 용산구


[Responsibilities] 
1) This position serves as a cluster lead for the Business Quality (BQ) for mature markets.
This position reports directly to the regional Business Quality and being a member of the regional Business Quality Leadership Team.
2) This position oversees BQ for 5 Local Operating Countries (Australia and New Zealand, Japan, Taiwan, Hong Kong and Korea) and collaborate with related internal quality group such as JSC ESI-Q, JSC Plant Quality and CLS.
3) In cooperation with the members of that team, the incumbent is responsible for implementing the Quality plan in his/her cluster ensuring alignment with commercial partners.
4) Ensure Quality Management system is deployed properly in the cluster in accordance with applicable standards, policies, and procedures as well as current and emerging regulations.
5) Ensure E2E quality oversight for all quality related items in his/her cluster and should be consulted by the Quality Head for Quality subjects/issues.
6) Ensure that the quality systems supporting the cluster business are in a constant state of readiness for planned and ad hoc regulatory audits or inspections conducted by regulatory bodies, competent authorities, or other agencies.
7) Accountable for the MR execution at country level in their cluster and being responsible to share the consolidated MR outputs at regional level.
8) Responsible to assure an adequate internal audit program is in place, as well as the action plan proposal and follow up plan.
9) Drive risk based Quality decisions in the cluster in cooperation with the local Quality Head, and will consult the regional BQ lead on decisions taken for product disposition in case of deviations.
10) Serve as the contact person for the country Quality Heads in case of level 1 escalations
11) Lead level 2 escalations for the cluster, prepare slide deck with all adequate information and oversee processes and follow up actions to address significant Quality issues in the Local Operating Countries.
12) Ensure PRC decks are robust and addresses all relevant inputs to the regional BQ Head in order to perform PAC meetings (slide decks, HHE, medical impact assessments)
13) Support the hiring, training, coaching and development of quality members in the cluster countries Local Operating Countries, including the goals and objectives definition and the performance appraisals of the quality Heads in the Local Operating Countries.

Leadership:
1) Oversees the development and execution of the BQ processes across the cluster
2) Provides leadership and ensures the operational success of quality functions within their cluster

Strategy:
1) Works with QHs to ensure alignment of BQ initiatives with business leaders

Tactics:
1) Ensures quality standards and processes are implemented in the cluster
2) Ensures appropriate risk management is performed to ensure proper decision making for Quality deviations
3) Develops CAPAs in collaboration with the QHs to mitigate risks

Compliance:
1) Communicates expertise and guidance on relevant regulations, directives on standards and industry guidance related to quality & compliance

Core Business:
1) Monitors performance and process metrics for the cluster
2) Provides direction, oversight, and development of cluster staff
3) Assures that an appropriate talent is on board to support the country needs


[Requirements]
1) At least 5 years of management experience in a regulated medical industry (Pharmaceuticals, Medical Devices, Consumer and / or Diagnostics).
2) Working knowledge of the business environment inside a quality organization,
3) Demonstrated knowledge of applicable regulations within the cluster
4) Ability to coach employees on quality and compliance topics
5) Knowledge of the business environment outside of the quality organization preferred (e.g., manufacturing, product / process development, customer service, distribution, commercial, etc.).




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www.careers.jnj.com -> Requisition number 검색 1700143904W -> 해당 모집 공고 클릭 후, “Apply Now”


[제출 서류]
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[서류 마감일] 
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[유의사항] 
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[이메일 문의]
recruitment-jnj@ITS.JNJ.COM