人材紹介株式会社 ジェイ エイ シー リクルートメント/JAC Recruitment Co., Ltd.
IT関連（その他） - 社内システム担当
・Develop， execute， review and approve all system test and user acceptance testing of computerized systems for the testing Center of Excellence.
・Manages budgets and business plans.
・Manages a regional group of employees， vendors， consultants and/or contractors responsible for testing services
・Design and implement the regional Testing CoE strategy.
・Define， develop and implement the procedures related to management and operations of the testing CoE.
・Deliver of IS/IT testing services.
・Develop and maintain the regional testing CoE annual budget including monthly reviews， forecasts and allocations. This includes managing the testing resources budget for up to 20 projects.
・Manages a group of testing analysts/consultants who test， evaluate， and validate IT systems and identify issues in software or services.
・Manage the hiring and performance of the IS/IT testing staff within area of responsibility， and guide the development of individual staff members to insure appropriate skills and behaviors exist to accomplish function goals.
・Define， execute and monitor quality metrics related to regional Testing CoE， and lead continuous process improvement activities.
・Partner with IS/IT managers who support client areas to plan， prioritize and schedule the resourcing of projects and services including the use of alternative resourcing models such as Offshore.
・Oversee design， development and delivery of training to Testing Analysts and consultants (i.e. Accenture， Randstad， etc.).
・Lead the activities for the definition and implementation of testing best practices， standards， and procedures for IS/IT systems.
・Represent during FDA or other regulatory agency inspections involving computer validation， electronic record/electronic signature， data integrity， and overall IT Systems Validation and Testing.
・Partner with IS/IT management and key affiliate contributors from R＆D， Commercial， and other affiliates to ensure corporate/local quality standards and policies are applied consistently across all IS/IT projects.
・Has in depth knowledge of and stays current on the System Life Cycle (SLC) methodology， IT compliance and computer system validation.
・Familiar with a variety of the pharmaceutical industry’s concepts， practices， and procedures. Relies on extensive experience and judgment to plan and accomplish goals.
・Provides consultation on complex projects and is considered to be the top level contributor/specialist for regulatory compliance and quality assurance for a project
※過去にジェイ エイ シー リクルートメント取り扱いの求人にエントリーされた方は、担当のコンサルタントまで直接お問い合わせください。
|勤務時間||9:00 - 17:30|
EDUCATION， EXPERIENCE AND SKILLS
・Bachelor’s degree and ten years IS/IT experience， or， High School diploma and twelve years IS/IT experience.
・Minimum of two years people management experience.
・Experience with validated computer systems.
・Ability to lead teams in the correct interpretation of regulations
・Demonstrated the ability to make quality decisions that will set precedence for systems development.
・Good oral and written communications skills， business acumen with problem solving and analytical skills
・Ability to write and speak the English language
LICENSES / CERTIFICATIONS
・American Society for Quality (ASQ)・Certified Software Quality Engineer (CSQE)
・Certified Quality Auditor (CQA)
・Quality Assurance Institute (QAI)・Certified Quality Auditor (CQA)
・Certified Software Test Engineer (CSTE)
|英語能力||流暢 (TOEIC 865点以上)|
|年収||日本・円 1200万円 〜 1400万円|