CMO Quality Manager (Consumer Healthcare)  /  グラクソ・スミスクライン・コンシューマー・ヘルスケア・ジャパン株式会社

職種 CMO Quality Manager (Consumer Healthcare)
社名 グラクソ・スミスクライン・コンシューマー・ヘルスケア・ジャパン株式会社
業務内容 【Job Purpose】
Reporting to the CMO Quality Group/Cluster Leader as a key member of the Supplier Relationship Team (SRT) this position is responsible for managing the relationship with assigned Contract Manufacturers (CMs) in the Region from a Quality perspective to ensure GSK’s product quality and reputation is protected.

【In this role】
you ensure that all aspects of the products at assigned Contract Manufacturers comply with the requirements of the GSK Quality Manual and meet relevant cGMP regulatory and legislative requirements through defined key performance and quality indicators
you assess the risk identify gaps and implement quality action plans at assigned CMs and you communicate to the organization so the risks are proactively addressed

Additionally this role will be accountable for establishing and maintaining an effective working relationship with the key contacts at each of the assigned CM(s). These include key contacts with (but are not limited to) Quality Regulatory Business Development Production Site Management and others.

The CMO Quality Manager in partner with the Supplier Relation Manager (SRM) must develop and maintain an effective working relationship with internal stakeholders and all members of the SRT including other members of CMO including Supply and Procurement Managers as well as contacts within Regulatory Technical Procurement relevant Category Quality functions.

【Key Responsibilities】
・Be the point of contact for Quality matters with the assigned Contract Manufacturers.
・Ensure that all aspects of the GSK products at assigned Contract Manufacturer(s) comply with the requirements of the GSK Quality Manual and meet all relevant cGMP regulatory and legislative requirements.
・Evaluate effectiveness of the CMO’s Quality Unit and systems and influence External Suppliers promoting robust systems under self sufficient organizations. Escalate all serious cGMP/Regulatory compliance issues. Monitor the quality performance of the External Supplier driving remedial action where necessary. Monitor and assess External Suppliers’ key performance indicators such as complaints and Right First Time as a mechanism to propose Continuous Improvement initiatives.
・Apply appropriate Risk Management tools with each CM/External Supplier in scope escalating and tracking significant risks requiring resolution including complaint monitoring and trending
求める経験 ■Minimum Level of Education
Degree in a Science or related discipline
Graduation in Chemistry Pharmacy Microbiology or another related science business degree is a plus
Area of Specialisation
Broad and thorough technical quality and regulatory knowledge of current pharmaceutical analytical and manufacturing techniques/ processes

■Preferred Level of Education
Master or PhD and at least 5 years experience AND/OR equivalency in education and experience.
Area of Specialisation
Science Pharmacy Chemistry Biology Microbiology Food and Nutrition

【Job Related Experience】
■Minimum Level of Job Related Experience required:
・5 years experience in various Technical and Quality Assurance roles.
・Breadth of knowledge and experience applying cGMPs and other regulations/guidance with an ability to interpret those in a fast paced environment.
・Previous assignment experience promoting or requiring global perspective desirable.
・Project Management skills and leadership skills
・Operational Excellence exposure.

■Other Job Related Skills/Background
・Demonstrated ability to be assertive.
・Demonstrated sense of urgency to complete the investigations including all necessary information to make decisions on batch disposal.
・Breadth in Quality Systems principles and practical application.
・Good knowledge and demonstrated application of Quality and Risk Management principles and tools.
・Demonstrated sound decision making process; based on facts data and application of Risk Management principles.
・Technical knowledge of multiple dosage forms.
・Demonstrated ability to effectively prioritize work.
・Demonstrated ability to excel at execution. Analytical and conceptual thinking required. Effective and sustainable solutions should be provided.
・Excellent verbal and written communication skills; with strong presentation skills.
・Strong interpersonal and negotiation skills; with demonstrated ability to influence stakeholders
・Strong problem solving skills with a disposition for continuous improvement.
・Demonstrated ability to work and collaborate in cross functional teams.
・Demonstrated intercultural skills. Capability to work with diverse and wide spread team.
・Demonstrated commercial acumen to effectively work with external companies
・Ability to adapt anticipate issues work under uncertainty and accommodate flexible work demands.
・Capable of working independently. A
語学力 英語力:中級
年収 900万円 - 1300万円
雇用形態 無期雇用






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GMP・GQP分野に特化した転職サイト。品質管理 品質保証 安全管理 生産技術開発 など(医療用・QTC医薬品/ジェネリック/医薬機器/化粧品 他)