[Janssen Vaccines] Quality Assurance Lead

Johnson & Johnson

4.2

(92)

Multiple Locations

Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020
  • 4.2/5 in overall job satisfaction
  • 4.2/5 in supportive management
  • 71% say women are treated fairly and equally to men
  • 88% would recommend this company to other women
  • 85% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
  • Global exercise reimbursement.
  • Two weeks off (one of them fully paid) for volunteer work.
  • #2406178623W

    Position summary

    ments 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]
    https://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.

    https://www.careers.jnj.com

    Qualifications

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    Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020
  • 4.2/5 in overall job satisfaction
  • 4.2/5 in supportive management
  • 71% say women are treated fairly and equally to men
  • 88% would recommend this company to other women
  • 85% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
  • Global exercise reimbursement.
  • Two weeks off (one of them fully paid) for volunteer work.