エージェント取り扱い求人

Head, Commercial Vaccines Quality, Japan

募集中
  • 勤務地
    山口県
  • 職種
    品質管理担当
  • 業種
    医薬品メーカー(先発医薬品)

募集要項

業務内容 ACCOUNTABILITIES
The role is accountable for the overall quality strategy and quality management system of commer-cial vaccines operations and supplies in Japan. The Head of commercial Vaccines Quality is respon-sible to design, deploy, monitor and improve the quality management system and for compliance to current Good Manufacturing/Distribution & Laboratory Practices and compliance to global standards and overall Hikari Site Standards.
The Head of commercial Vaccines Quality partners with the GMS site quality head and aligns on site quality strategy, a harmonized cross-plant quality philosophy & joint quality initiatives and main-tains good day to day collaboration between the 2 site quality organizations.
Ensures that new/revised quality system requirements are deployed to the site timely. Ensures execution leads for Quality-owned business processes are established who work with the business process owner to continually execute compliantly & improve on site processes.
Responsible for Japan vaccine quality performance, continuous improvement and Q-metrics (KPI) monitoring to ensure global and site targets are achieved, met and countermeasures are in place when applicable.
Responsible for Quality Control testing and sampling for commercial vaccines (Bulk Drug Substance and Drug Product (BDS, DP)) and partners with other laboratories or external laboratories for testing that is performed on behalf of vaccines quality (eg. Microbiology, Environmental Moni-toring, Raw Materials)
Responsible to establish the appropriate quality oversight for outsourced activities such as testing as well as quality assurance review of site validation activities.
Development and refinement of groups’ specific quality systems and procedures.
Committed to continuous improvement and responsible to proactively mitigate current and future risks to maintain an effective operation to support business needs.
Living values and fostering a Quality Culture culture of trust and and speak up culture within the team.
Assuring appropriate GMP and QA systems training of Quality personnel and continuously develop team´s capabilities and expertise.
Accountable for quality oversight of site quality management systems (CAPAs, Change Controls, Deviations, Formal Risk Management, facility/equipment/process qualification)
Responsible for site specific QMR management and gathering of APQR data. Align with GMSGQ team and provide QA support for electronic system integration: LIMS, Trackwise, SAP etc.
Responsible for vaccine batch disposition decisions taking into account all relevant information and escalation processes. Oversight of execution of product disposition (drug substance).
Responsible to ensure sufficient and adequate quality oversight of vaccines manufacturing and distribution processes.
Preparing for/ supporting/ leading internal and health authority regulatory inspections and third-party audits, including communicating with and providing information to regulatory submissions or bodies.
Responsible for timely updates of site achievements and challenges to management with a focus on quality compliance, operations performance, staff performance and productivity/training, staff development, continuous improvements, key projects support and identification and resolving obstacles to maintain a highly effective and productive functional group.
Responsible for management of cross-plant quality issues and timely escalation of vaccines related issues within the global VBU organization.
Responsible for budget planning and managing expenses and for timely hiring, training and devel-opment of qualified staff to ensure effective execution of roles and responsibilities, GMP compli-ance, and attainment of operational and development goals.
DIMENSIONS AND ASPECTS
Knowledge and experience of Biologics manufacturing
Knowledge and understanding of Health Regulations applicable to local and other markets supplied
Knowledge and understanding of industry, scientific and regulatory trends, established prod-ucts portfolio and market conditions to evolve regulatory and quality profile
Strong analytical and problem-solving skills (preferably Lean & 6 Sigma background).
Leadership
Ability to lead a Quality organization of internal manufacturing with full accountability for all aspects of performance of respective site (Customer Service Levels, GMP compliance, EHS compliance, Opex Cost Savings, lab transformation, People Culture & Change)
Ability to build a customer & patient-centered, best in class organization, develop diverse talent and elevate organizational performance
Ability to make and recommend Quality decisions impacting Market Actions etc., enabling to deliver on its commitment to put patients first and build trust with society
Decision-making and Autonomy
An active member of Site Leadership teams and vaccines quality teams
Responsible for decision making that balances progress on global initiatives with local priorities
Responsible for Vaccines Quality governance (Quality Councils / Management reviews)
Responsible for active and timely Incident notifications and associated escalation activities
DOA limits to be defined in line with new TMAP
Interaction
Key stakeholders include: global & Japan VBU, Global Manufacturing and Suplly site Quality, Procurement, Supply Chain, Regulatory Affairs.
Local Board of Health Agency, National Control Laboratory
雇用形態 正社員
応募資格 Languages

English: Fluent written and spoken
Other languages as applicable
Experience

Between 12 - 15 years of management experience in Quality in a GMP environment in the Pharmaceutical Industry, minimum of 5 years of vaccine QA leadership experience.
Specific Knowledge

Advance knowledge of good manufacturing practices in Japan, its various guidelines as well as international standards such as FDA, EMA, PICS, WHO, USP, JP, EUPharmacopeia etc.
Should be current in knowledge of state-of-the-art processes and systems related to production as well as quality control of the products, including Digital/Automation concepts
Mandatory Certifications

Leadership ability, decision-making, resilience and development of people and teams.
Behavioral Competencies:

Ability to focus on few key priorities and demonstrate strategic enterprise thinking
Ability to deal with ambiguity
Patient and customer-centric
Very strong ability to drive and manage change
Experience leading teams in an highly regulated environment
Ability to inspire and build trust within teams and across networks
Strong analytical abilities in order to make competent decisions based on the review of data
Strong attention to detail in regards to data integrity, data collection and data analysis
英語力 問わない
年収 1300万 〜 1700万円
給与詳細 1300万円-1700万円
勤務地 山口県
備考 unwavering in our commitment to patients. With the patient at the center of everything we do, we continue to innovate and drive changes that will better their lives - we’re looking for like-minded professionals to join us.

the number one pharmaceutical company in Japan and a global industry leader –we are united by our four priorities (Patients, Trust, Reputation, and Business) and our shared values of ism: Integrity, Fairness, Honesty, and Perseverance. ism is more than just a word. It’s a belief and a mindset which guides our decisions, behaviors, and interactions. It’s how we strive to work and live, every day.

企業情報

匿名

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