[Janssen Vaccines] Sr. Quality Compliance 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: Sr. Quality Compliance Lead

2. 계열사: 얀센백신 (Janssen Vaccines)

3. 근무지: 인천 송도

4. 근무 형태: Regular 

[Responsibilities] 
Responsible for ensuring the robust implementation and sustainability of the compliance programs designed to protect our customers, the company, and individual employees against regulatory compliance requirements in the areas of sourcing, production, storage, shipping, distribution, and post-market surveillance of Johnson and Johnson products. 

1. Team Accountability
   The work scope of Quality Compliance team is as followed. 

• Serve as a lead host during health authority inspections and J&J independent audits (e.g., ERC/JJRC)
• Provide guidance and assistance to site management and employees to ensure process procedures are compliant 
• Carry out internal audit and monitoring programs to ensure the robust implementation and sustainability of the quality and compliance programs. 
• Establish and maintain site inspection readiness plan and monitor remediation activities. Provide periodic progress/status updates to site management. 
• Identify and communicate compliance status and common issues/trends via an independent audit assessment process, including appropriate rating of internal audits 
• Document all assessment findings and commitments accurately and timely in the Enterprise Quality and Compliance tracking systems and verify that those commitments have been taken and are effective. 

2. 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 suggest resource allocation as necessary.

• Prepare and manage business unit budget.

• Manage team performance and succession planning through effective communication, coaching, training, and development.

• Evaluate performance and provide feedback. Implement disciplinary actions, as necessary

[Requirements]

1. Required skills

• Minimum of University/ Bachelor’s degree or Equivalent in Pharmacy, Life Science or Engineering related to pharmaceutical or biopharmaceutical technology
• Minimum 5 years in a leadership role within a global supply chain in pharmaceutical industry, preferably in biotechnology industry
• Knowledge and experience in GMP quality systems, FDA/EU regulations & guidance related to sterile pharmaceutical manufacturing, and health authority inspections and audits.
• Minimum 3 years in auditor role 
• Experienced in health authority inspections as a lead host
• Demonstrated leadership to influence and negotiate across the organization at all levels
• Strong decision making, problem-solving, and risk management competencies
• Ability to operate in a global matrix organization with multiple stakeholders. Strong enterprise & customer centric mindset and networking.
• Strong communication skills in Korean. Good working proficiency in verbal and written English.

2. Preferred skills

• Good technical writing skills

• FDA audit handling experience 

• Sterile Drug product related experience

[지원 방법] 
www.careers.jnj.com 접속 -> Position Number 2206061226W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행 

[제출 서류]
영문 자유 양식의 이력서/자기소개서

[서류 마감일] 
채용시 마감

[For more Johnson & Johnson]

• J&J Careers 유튜브 채널 : https://www.youtube.com/channel/UCZEsWOZwbcjcXHrgYq7sP4Q

• J&J Korea Facebook: https://www.facebook.com/JNJCareersKorea/

• J&J Linkedin: https://www.linkedin.com/company/johnson-&-johnson/

• J&J Corporate Page: http://www.jobkorea.co.kr/Company/1605233/Info

[유의사항] 

• 서류를 MS-Word 나 PDF 로 된 한 개의 파일로 미리 준비 하시기 바랍니다.
• 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연 될 수 있습니다. 
• 온라인 접수시 “Create Your Account” 를 통해 개인 이메일 계정을 등록하신 후 온라인 지원 프로세스를 진행할 수 있습니다. Ex) G-mail/Naver/Daum 등
• 모집 분야 관련하여 자세한 내용은 J&J 홈페이지에서 확인하시기 바랍니다. www.careers.jnj.com