Contract Operations Quality Assurance Manager
辉瑞制药有限公司
- 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:2015-03-26
- 工作地点:上海
- 招聘人数:1
- 工作经验:8-9年
- 学历要求:本科
- 语言要求:英语熟练
- 职位月薪:面议
- 职位类别:药品生产/质量管理
职位描述
Role Description |
The Manager COQA is accountable for providing quality assurance management of key contractors for Pfizer and for assuring that the products supplied to our patients are manufactured, tested in accordance with c-GMPs, the registration file and any additional country specific requirements. This is highly independent position operating with minimal supervision, interacting with high levels of management both at contract manufacturers and within Pfizer. Will operate as spokesperson for COQA and will spend a significant period of time developing relationships, independently negotiating, developing and communicating Pfizer quality requirements with contract manufacturers. The COQA Manager will have significant interactions with many internal business and manufacturing organizations (e.g., GES, GMC, GMS, QO Center, PGM sites and PGRD) and will lead virtually based cross functional teams. |
Qualifications: Education - Experience - Additional Requirements |
· Minimally BA/BS Science, Engineering, or related technical discipline with at least 8 years in a GXP setting · At least 4 years of Product Quality Assurance experience in a GMP environment · Experience with external suppliers/contractors is preferred · Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, Documentum platforms · Command of English language required and multi-lingual is beneficial. · Strong verbal and written communication including presentation skills · Up to 30 % travel required. · Shows strong negotiation skills and is diplomatic in communication with internal and external customers · Demonstrated ability to manage multiple projects · Demonstrated ability to prioritize work, to act and work independently and to report items as required to Team leader · Has excellent organization skills · Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor · Developing personal leadership to manage cross functional projects · Developing ability to resolve conflicts · Takes initiatives and is proactive, persistent · Has a broad GMP and technical know-how to handle emerging issues |
Application of Knowledge and Skills | |
Breadth and Depth of Knowledge | Has extensive knowledge of the principles, concepts and theories of the discipline, and working knowledge of principles and concepts of other disciplines |
Application and Complexity of Technical Knowledge | Applies technical and line knowledge of key concepts in own discipline and may act as a key technical resource within discipline Applies knowledge of internal/external business challenges to provide input into recommendations for improvements to products, processes or services |
Innovation and Risk-Taking | Begins to create an environment that supports experimentation beyond self. Takes appropriate risks to advance new concepts and methodologies that are moderately complex |
Decision Making and Autonomy | |
Complexity of Decisions (e.g., Complexity of Solutions, Ambiguity) | Makes decisions that may require developing new options to resolve complex problems Makes decisions guided by policies in non-standard situations Operates independently in ambiguous situations within department; decisions may directly affect department ability to deliver its objectives |
Impact of Decisions | Decisions impact work group/project team or department and its customers; decisions affect program/project delivery and may impact expenditure on existing/alternative resources |
Judgment | Exercises judgment utilizing breadth of knowledge and prior work experience. May become a resource for others |
Direction Received | Works independently. Receives instruction primarily on unusual or complex problems. May independently develop approach to solutions Exercises considerable latitude in determining objectives of assignments |
Review of work | Generally reviews own work. Solicits directional review from others. May review work completed by other colleagues when acting in mentor role |
Resource Management and Teamwork | |
Complexity and Scope of Responsibility | Provides guidance to and/or may lead/co-lead projects Manages own time to meet objectives; forecasts and plans resource requirements (people, financial and technology) for projects |
Scope of Team Influence | Develops constructive relationships across disciplines and function. Represents work group/project team or department on cross-line teams |
Role in Team Interaction | Regularly takes informal leadership role during team meetings to facilitate agreements and move the team toward its goals. Takes responsibility for a portion of the team's milestones/deliverables. May lead (virtual) operational team(s) |
Leadership | |
Communication | Uses a variety of communication tools and techniques to explain difficult concepts and persuades others to adopt a point of view |
Behavioral Competencies | |
· Functional / Technical Skills · Acts Decisively · Seizes Accountability · Grows Self · Change Agile · Self Awareness · Commits to “One Pfizer” · Peer Relationships | · Deal with Ambiguity · Decision Quality · Customer Focus · Negotiating · Composure · Perseverance · Conflict Management · Standing Alone · Project Management |
Our Values |
· Committed to the Needs of our Customers (Customer Focus) · Give Back to the Community (Community) · Treat Others with Dignity and Respect (Respect for People) · Think Strategically and Execute Flawlessly (Performance) · Demand / Demonstrate Teamwork (Collaboration) · Ability to Engage Teams (Leadership) · Be a Role Model (Integrity) · Right First Time (Quality) · Think Broadly (Innovation) |
公司介绍
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元,研发投入78亿美元。辉瑞在全球拥有9万多名员工,59家生产基地,业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域,同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中,辉瑞始终致力于奉行严格的质量、安全和价值标准。每天,分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。
辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作,支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来,辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个,其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗,辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓,并以其优异的品质深受广大消费者的青睐;辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.
联系方式
- Email:chinahrwest@Pfizer.com
- 公司地址:南京西路中信泰富