quality assurance gxp senior manager (大手外資系製薬会社).

Job DescriptionThe Senior Manager, New Oral Solid Product introduction, will be responsible for Quality oversight of NPI projects of oral solid dosage for Japan market, and ensure launch readiness for commercial supply. The candidate will be a representative of Japan Quality at NPI projects to global and domestic stakeholders, especially focused on the development, commercial launch and the steady supply for the designated product. The Senior Manager is expected to have strong experience in new product introduction of Oral solid dosage, GMP/GQP/GDP, and quality management systems.Responsibilities include assuring products meet specifications and comply with regulatory requirements. This position provides quality oversight for internal and/or external contract manufacturing including production activities, analytical testing, warehousing, and distribution.You will be responsible for:- In coordination with the Associate Director, Quality Country GxP Compliance Japan, the Senior Manager will work to embed Quality requirements into NPI projects and ensure the readiness of the products for Japan NDA and commercial supply.- Act as Quality representative of Market Authorization Holder (MAH) to release the products in Japan market in the term of GQP ordinance and manage the wholesaler from GDP perspective.- Establish ways of working with external business partners including related overseas CMOs for drug substance, the finished products and so on, to ensure their suppliers staying compliant with Japan regulatory requirements and policies.- Act as Quality liaison of the company between the local business operational groups, global project team for new product introduction, and external business partners.- Partner with local and global Quality groups to foster a proactive approach to compliance.- Oversee the integrity of local Quality Control Laboratory (CLO)- Ensure that company policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with global and local GxP guidelines.- Ensure company, local and global, is kept fully informed of new or emerging GxP and regulatory changes in Japan.

求められる経験
Requirements:
- Strong hands-on GMP/GQP, 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 and new drug application (NDA).
- Thorough knowledge of GMP/GQP; Product release, Change control, Complaint management, and Quality agreements.
- 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
- Holistic understanding on a broad range of pharmaceutical activities and Quality Systems.
- Strong stakeholder management skills

保険
健康保険,厚生年金保険,介護保険,雇用保険,労災保険

休日休暇
日曜日,土曜日,祝日

給与
年収800 ～ 1,300万円

賞与
-
雇用期間
期間の定めなし