Regional ESQA Lead, APAC
硕腾(上海)企业管理有限公司 Zoetis Enterprise Management (Shanghai) Co., Ltd.
- 公司规模:5000-10000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2021-01-12
- 工作地点:上海-长宁区
- 招聘人数:若干人
- 工作经验:3-4年经验
- 学历要求:本科
- 语言要求:英语熟练
- 职位类别:总监/部门经理
职位描述
POSITION SUMMARY
This position reports to the QSS/ESQA Lead, and will serve as the senior most ESQA leader for the External Supply organization in APAC region. The Regional ESQA Lead, APAC will have overall responsibility to assure quality objectives are met by Zoetis external contracted partners (CMOs/Suppliers) in APAC. The Regional ESQA Lead, APAC will have regional direct reports (i.e. ESQA APAC team) and will serve as a partner alongside other stakeholders (e.g. VMRD, VMRA, GMT and Commercial colleagues) to enable ESQA business objectives by meeting required quality objectives.
The Regional ESQA Lead, APAC will oversee the risk-based approach to managing quality aspects of external partners located in this region that include: contractors and suppliers. The use of appropriate metrics and trending of data is expected for daily assessment of external supplier quality status and guidance.
The Regional ESQA Lead, APAC will work closely with GES and GSS organizations to coordinate business activities; communicate priorities; problem solve; and proactively work to maintain product supply.
The role is responsible for the oversight and use of key tools such as Quality Agreements and Quality Councils to insure that the quality and compliance aspects of Zoetis product delivery is met by all external suppliers located in APAC.
The Regional ESQA Lead, APAC will develop longer term Quality Strategy objectives and Quality Roadmaps for ESQA APAC to keep the region compliant with applicable quality regulations, maintain agility, and ensure effectiveness across the Business.
The Leader will establish/maintain appropriate processes and metrics to manage the APAC ESQA unit and enhance problem solving at regional level of the quality organization. ESQA Quality Council Leadership is essential to realizing the overall Quality Culture for the regional Business.
POSITION RESPONSIBILITIES
Organizational Quality Responsibilities
1.Serving as a quality culture role model, and promoting a strong Quality & Compliance culture in ESQA APAC region that translates into a First-Time-Right mind-set and insures the effectiveness of the Quality Management System.
2.Insuring Quality System Standards and Processes are appropriate and up to date for ESQA APAC
3.Develop long-term Quality strategy for the ESQA APAC operations.
4.Organizational Goals translated/adapted to ESQA APAC goals.
5.Creation / Management of the Quality Roadmap for ESQA APAC.
ESQA Functional and Process Responsibilities
1.Development and Management of ESQA APAC Process Goals and Metrics.
2.Develop and Maintain the appropriate Risk Management Process and mechanisms for managing ESQA APAC Contractors and Suppliers.
3.Insure adequate Quality oversight is provided for ESQA APAC Contractors, Suppliers, , Repackers.
4.Where required, insure Quality Agreements are in-place and in-use in ESQA APAC.
5.Lead strategic and tactical deployment of problem solving and other methodologies leading to continuous improvements in ESQA APAC, Monitoring CAPA effectiveness at each respective location.
6.Assuring the use of operational excellences tools in quality processes
7.Establish and Co-Lead the Quality Governance Council for the ESQA APAC with the GES APAC Lead, to inform management about product quality and process performance, quality risks, compliance with internal and external requirements.
8.Use trended metrics and audit data to drive initiatives for increased performance.
9.Manage the reporting of applicable metrics for the ESQA APAC organization.
10.Maintain linkage to Surveillance and Audit services to fully evaluate ESQA APAC Sites’ regulatory compliance position
11.Understand Key Points of Compliance (KPCs),Standards, and Processes specific to the Products produced by Contractors and Suppliers in APAC.
Staff and Leadership
1.Leadership Development / Coaching of Staff; Creation of Learning Organization
2.Insure Training and Development plans are in place for ESQA APAC associates.
3.Developing QA operations budget and resources planning for ESQA APAC
4.Driving the Quality Culture Change and Quality Enhancement Program for the Technology ESQA APAC
ORGANIZATIONAL RELATIONSHIPS
1.Corporate Compliance/Audit Group
2.Manufacturing GMT
3.VMR&D
4.GES; GSS
5.GMS Functional Operations (ie: HR; Procuement etc)
6.VMRA
7.SCQO
8.Commercial Operations
9.Manufacturing IT
RESOURCES MANAGED
Financial Accountability
Annual Operating Budget anticipated: $1.2-2.0 ***
Supervision
1.The role will give direct supervision to 8-10 Quality Leaders.
2.Highly matrixed organization; Influence without authority necessary
EDUCATION AND EXPERIENCE
1.Science or Engineering Bachelors / Masters Degree
2.Solid Operations and/or Quality experience (5+ years) in Animal Health/Human Health manufacturing
3.Ability to understand and communicate with a wide range of external business models/entities
4.Problem solving in a volatile environment
5.Previous Leadership experience – preferably regional and leading the management of contracted entities
6.Demonstrated ability to operate successfully in a matrix organization
7.Fluency with ICH Q10 Preferred
8.Six Sigma Black Belt / Green Belt or Lean Practioner Preferred
9.Experience in working with FDA, EU, Chinese regulations.
TECHNICAL SKILLS REQUIREMENTS
1.People Management / Demonstrated Leadership Skills
2.Demonstrated success in a Quality Operations Role
3.Sets Clear Direction and Aligns Team and Others Around Common Objectives
4.Ability to communicate and influence broadly – especially with external entities
5.Working knowledge of contract law and business development
6.Ability to analyze data and synthesize to make data driven decisions
7.Ability to Develop and Implement Strategic Initiatives
8.Business Acuumen
9.Process Owner Management
10.Change Agent; Passion to win and can be successful in managing a change environment
11.Continuous Improvement and break-thru thinking
PHYSICAL POSITION REQUIREMENTS
1.Shanghai, China based position
2.Position requires flexible work hours, to accommodate varying teams and markets’ time zones
3.This position will require fluent use of teleconferencing and Webex tools, as well as Sharepoint technologies, to share and manage information with global locations and manufacturing sites
4.Travel: Estimated 20% regional travel
ACRONYM DEFINITIONS
QSS: Quality Systems and Standards
QA: Quality Assurance
QC: Quality Control
GES: Global External Supply
ESQA: External Supply Quality Assurance
SC QO: Supply Chain Quality Operations
GMS: Global Manufacturing and Supply
VMRA: Vetrinary Medicine Regulatory Affairs
职能类别:总监/部门经理
公司介绍
Zoetis is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience, we deliver quality medicines and vaccines, complemented by diagnostic products, genetic tests, biodevices and a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals.
Why Zoetis
Zoetis has more than 60 years of experience in delivering innovative, high-quality products and services that benefit our customers.
Zoetis work environment
At Zoetis, we take pride in a collaborative spirit and high-performing environment where every colleague is given room to learn and grow.
Your opportunities at Zoetis
We invest in our people and offer diverse and exciting opportunities to make a difference in a growing global industry while shaping the future of animal health.
Results that matter
Our colleagues make an impact by working hand-in-hand with those who raise and care for animals to better understand and address the unique real-world challenges they face.
硕腾,原为辉瑞的动物保健部门,作为一家全球领先的动物保健公司,致力于为客户及其业务提供最有力的支持。秉承60年的悠久历史,我们为用户提供优质的兽药和疫苗、业务支持和技术培训。
在《福布斯》“2017年美国***雇主(中型企业)”中硕腾公司也有幸入选,这是硕腾公司第二年入选,排名在Top300中列114位。这份殊荣是对硕腾的工作环境、公司文化和企业品牌的认可。我们将继续不懈努力,帮助饲养和关爱动物的人们,为他们解决所面临的各种挑战。
我们的英文名字Zoetis (zō-EH-tis),其词根为zo,以 zoo(动物园)和zoology(动物学)而广为人知。Zoetis源于zoetic(有生命的,有生气的),蕴含“赋予生命的意义”之义。硕腾(Zoetis)致力于为世界各地的饲养和关爱动物的兽医和畜牧从业人员提供支持。
联系方式
- Email:tianlong.wu@zoetis.com
- 公司地址:上海市虹口区四川北路88号星荟中心2座21-22楼