Johnson & Johnson Careers
[Consumer] R&D Quality & Compliance Manager
Requisition ID: 1805700225W
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: R&D Quality & Compliance Manager
2. 계열사: 존슨앤드존슨 컨슈머 (Consumer)
3. 근무지: 서울시 용산구
Oversight of end-to-end quality integration and governance of partner enabled initiatives (PED) in Asia Pacific, ensuring compliance to regulations, Enterprise Policies and Standards, company guideline, and global procedures
- Main contact and voice of Quality in partner enabled development initiatives. This role will connect with other Q&C teams (Make, Source, Business and CLS Quality) ensuring that Q&C has coordinated support and inputs on PED initiatives
- Provides end-to-end Q&C leadership and direction in PED project teams and business partners; actively engages in identifying compliant solutions to [potential] issues or road blocks.
- Responsible for executing/implementing quality systems and controls that are appropriate, effective, efficient and continuously improving in order to ensure that R&D functions are operating in full compliance with sound scientific practice, current Good Manufacturing Practices (cGMP), regulations and Enterprise Policies and Standards.
- Provides leadership, direction and oversight of R&D Compliance for documentation quality review/approval or audits (including but not limited to standard operating procedures, batch records, packaging dossiers, protocols, Certificates of Analysis, process/analytical reports, method validation reports, test methods, specifications, deviations/investigations and R&D Quality Agreements), study materials release, and internal auditing
- Provide guidance on applicable Regulations to project team members and business partners.
- Minimum Bachelor’s degree with experience in overall product development process
- Expert knowledge of applicable regulatory requirements (cGMPs and cGLPs) governing various product classification types (cosmetic, OTC/OTC Monograph and Medical Devices).
- Identify leveraging opportunities and solutions, and coach others to do the same.
- Ability to provide guidance, collaborate, negotiate, and influence partners ensure an ongoing state of compliance
- Ability to engage and align with other diverse and dispersed organizations and functions.
- Ability to negotiate, influence and lead with and without direct line authority, and to engage others and lead an organization through continuous improvement and change.
- Ability to work and make compliance decisions independently and on multiple projects.
- Fluent in English both oral or written
[JD 확인 및 지원 방법]
www.careers.jnj.com 접속 -> Position Number 1805700225W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행
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Johnson & Johnson Korea (8265)