Job Description
希少疾患のリーディング企業
■ 職種: Associate Director, Regulatory Compliance & Quality
■ 会社概要:
・ 希少疾患のリーディング・カンパニー
・ パイプライン:希少疾患のパイプが複数。既に複数は販売開始されている
・ ローカルに権限移譲されているためにローカルの意向が尊重
・ 本社や海外よりも日本が先行して申請も可能
・ MRが入社したい企業のトップランク
■ 職務内容
(雇入れ直後)Associate Director, Regulatory Compliance & Quality
You will be responsible for:
Quality professional with strong subject knowledge, both in depth and breadth. Experience from a number of different areas of quality. Will control, monitor and develop systems and procedures to enhance the approach quality across multiple disciplines.
Responsible for managing and improving quality assurance systems and procedures across multiple disciplines within Quality. Leads a team of quality professionals, closely together with Hinseki.
Facilitates the production and distribution by performing tasks associated with GQP/GDP for production and distribution, such as creating SOP, managing and collaboration with contractors, shipping products to the market and quality assurance at the distribution process, CMC compliance and GMP periodical review.
Working collaboratively with Global related department (CMC, RA), gathers correct information of overseas manufacturing facilities.
Makes an application for change management on the application form for approved products appropriately and obtains the approval.
Make an appropriate budget and proposal for quality assurance.
Partner with local and global Quality groups to foster a proactive approach to compliance.
Ensure that Alexion policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with global and local GxP guidelines.
Proactively work together with stakeholders and ensure Alexion, local and global, is kept fully inplemented new or emerging GxP and regulatory changes in Japan.
Ensure all MAH requirements are appropriately implemented and proactively propose and execute any improvements on all GxP activities to support Soseki.
(変更の範囲)会社の定める業務
■ 応募資格
You will need to have:
Strong hands-on GQP/GMP, New Product introduction, Quality Assurance / Compliance experience in pharmaceutical industry.
Exceptional Global communication and interpersonal skills, and ability to work globally in a matrix environment.
Business English level.
Accountability and commitment for outcomes and project completion.
Thorough knowledge of applicable local and global regulatory requirements required for GxP compliance/ MAH organization, and experience of creating/ implementing a new operation system into related organization.
Thorough knowledge of GQP/GMP; Product release, Change control, Deviation control, Complaint management, Compliance to approved document, HA inspection, FMA management, HA interaction and Quality agreements and so on.
Thorough knowledge of CMC science such as the process validation, QC testing and so on
Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs.
Comprehensive understanding on a broad range of pharmaceutical activities and Quality Systems.
Strong stakeholder management and collaboration skills.
Qualifications:
Minimum of 5 years work experience in GQP/GMP and/or Drug Product development work at a pharmaceutical company.
Must have experience in drafting/negotiating/concluding QAG (Quality Agreement) with CMOs.
Experience in setting SOPs that requires establishment of new business scheme for Quality Management is preferable.
More than 5 years of experience in GQP/GMP work for products of biological origin is preferable.
Must have knowledge of pharmaceutical regulations for products of biological origin including MAH, GQP, GMP and CMC.
Education:
Bachelor's degree or higher in pharmacy or science major.
Proficiency in Japanese
Proficiency in English to communicate with Global staff. (conference call, email)
Competencies:
Decision Quality
Functional/ Technical Skills
Motivating Others
Attracts and Develops Top Talent
Optimizes/ creates new Work Processes
■ 就業場所
(雇入れ直後)東京都
(変更の範囲)会社の定める場所
■ 給与
・現職、経験により考慮
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