인재풀 - Compliance Manager - APAC (South Korea)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Senior Compliance Manager - Make an Impact at the Forefront of Innovation
The Senior Compliance Manager identifies, develops and executes quality and compliance strategies and initiatives across the organization, including promoting awareness of advanced quality and regulatory compliance standards and trends. This role leads and/or reviews complex internal and external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. The Senior Compliance Manager performs technical document review and other GxP practice activities in support of clinical development programs. Additionally, oversees governance and compliance management processes; develops and leads quality and compliance guidance/reference materials and tools, and provides expertise to advance the vision of the department.

Compliance Manager - APAC (South Korea)

What You'll Do:
• Lead, review, and approve reports for a variety of client, internal, or GxP audits and regulatory inspections.
• Lead quality and compliance processes and engage with a variety of cross departmental staff to ensure appropriate execution and completion.
• Develop and effectively share guidance and reference information, repositories, and communication channels including policies, procedures, guidance documents, or quality management systems training.
• Lead process/quality improvement initiatives.
• Develop tools and other materials for tracking of compliance management activities, and analyze trends.
• Mentor less experienced staff and serve as project lead for group projects.
• Create formal networks with key contacts outside the department.
• Identify and resolve issues impacting the quality and/or integrity of clinical research programs, determine root cause of non-conformance and develop strategies to address issues.
• Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings.

Education & Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years’) or equivalent combination of education, training, & experience.


In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities:
• Expertise in applicable GxP and appropriate regional regulations
• Extensive knowledge of the clinical trial process
• Expert knowledge of SOPs and WPDs
• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
• Strong training/mentoring experience of staff on a variety of process/topics
• Strong attention to detail
• Effectively works independently or in a team environment
• Highly developed problem solving, risk assessment, and impact analysis skills
• Strong negotiation and conflict management skills
• Strong organizational and time management skills including ability to multitask and prioritize competing demands/work load
• Strong computer skills; ability to learn and become proficient with appropriate software
• Proven flexibility and adaptability
• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

 

「인재풀 등록 시 고지 및 동의에 관한 안내」

귀하께서 인재풀에 등록하실 경우, 당사는 『개인정보 보호법』 제15조 및 제22조에 따라, 아래와 같은 목적을 위하여 귀하의 개인정보를 수집·이용할 수 있으며,
이에는 채용 관련 정보 제공 및 뉴스레터 발송이 포함됩니다.

• 수집·이용 목적: 채용 기회 안내, 채용 뉴스레터 발송, 향후 채용 포지션에 대한 적합 후보자 선정

• 수집 항목: 성명, 연락처, 이메일 주소, 경력 및 이력 정보 등 인재풀 등록 시 제공한 정보

• 보유·이용 기간: 인재풀 유지 기간 또는 수신 거부 요청 시까지

• 수신 동의: 인재풀 등록 완료 시, 위와 같은 정보 제공에 사전 동의하신 것으로 간주되며, 언제든지 수신 거부 및 정보 삭제 요청이 가능합니다.

수신을 원하지 않으실 경우, 등록 후 제공되는 ‘수신 거부’ 절차를 통해 변경하실 수 있습니다.