주요 업무 내용
- Responsible for ensuring the robust implementation and sustainability of the compliance programs designed to protect our customers, the company, and individual employees against government allegations of fraudulent or abusive practices in the areas of research, medical, education, marketing and selling of Johnson and Johnson products.
- Manages activities for the quality assurance and compliance of clinical and preclinical trial activities.
- Ensures that compliance and scientific objectives are being met through the accurate and timely reporting of study scheduling, progress, and resources.
- Manages maintenance of consistent procedures involving standard operating procedures management, document flow, archiving and regulatory practices.
- Enforces internal policies and procedures to assure that the privacy programs are operating under a state of control and in a manner consistent with applicable laws, regulations and policy.
- Uses established written policies to ensure implementation of appropriate quality documents and procedures to assure day-to-day decisions are well supported, and clearly and properly documented.
- Oversees appropriate monitoring systems and analyzes periodic audits.
- Manages investigations: reviews and evaluates documents and records, personnel and investigator interviews and report drafting.
- Results of investigations are documented and submitted to appropriate management.
- Manages immediate staff and acts as subject matter expert for the department.
- Good knowledge on internal/external GMP regulations
- At least 8 years of work experience
- Advanced knowledge and competency on Quality Systems. (CAPA, Change Control, Event/Deviations, etc.)
- Skills of problem solving, risk assessment, analytical thinking, data analysis, process setting
- Experience of MFDS, internal audit and supplier audit
- Fluent English writing and speaking
- Above bachelor’s degree