天津招聘

Responsibilities:
1. Communication Interface between Affiliates and Global Clinical Development Quality Assurance
a. Point of contact for quality issues rose from local/regional trials.
b. Ensures rapid communication of quality issues including potential misconduct or issues of significant deviations with project/products to appropriate leaders, colleagues and R&D QA Leadership Team.
2. Supports the planning, prioritization and implementation of an affiliate audit program through the auditing group in R&D QA.
a. Identifies areas of specific affiliates-related risks.
b. Provides GCP advice and promotes building quality measures into routine business process in the affiliates.
c. Provides GCP training for affiliates where and as needed in close collaboration with the training group.
3. Works with R&D QA Inspection Management Lead to coordinate the local support for Regulatory Authority & Ethics Committee/IRB inspections.
4. External Customer Focus
a. Participates in regional vendor qualification
b. Performs quality risk assessments of regional vendors
c. Supports the management on quality issues or deviations related to regional development vendors
5. Process Improvement
a. Supports the harmonization of best practices and projects across the region, function and other quality function e.g. Clinical Operation Quality Lead
b. Supports the implementation of process improvements and provides feedback on effectiveness of implementation, challenges and best practices.
6. Participates in special assignments in various projects and work streams as determined by R&D QA Management.

Requirements:
? University degree in scientific or quality-related subjects. Advanced degree in relevant subjects preferred. Equivalent relevant professional experience may be considered.
? Minimum 6 years QA experience or relevant experience in international pharmaceutical and/or biotech industry, in particular clinical quality management, clinical development, or regular compliance with a minimum of 2 years in Clinical QA.
? Basic knowledge/expertise in continuous improvement with background in appropriate tools/procedure e.g. strong quality orientation and understanding of metrics; Lean Six Sigma training; demonstrated knowledge of Root Cause Analysis techniques
? In depth knowledge of applicable worldwide regulations and ICH guidelines.
? Basic knowledge of other GxP disciplines like GLPs or GMPs or GPvP.
? Solid working knowledge of principles and concepts of risk-based Quality Assurance.
? Broad understanding of the drug development process and regulatory environment including specific areas of interest for Merck Serono e.g. biotherapeutics, oncology and emerging markets.
? Demonstrated good interpersonal, communication, organizational, presentation skills, influencing, and problem-solving capabilities.
? Demonstrated ability to work independently and manage time efficiently and effective.
? Demonstrated awareness of cultural differences and impacts of team/personal behavior.
? Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.
? Understands and appreciates the impact of integrity, gaining and keeping trust and working effectively in a changing environment.
? Ability to adapt to changing direction and needs of the business and can directly apply this knowledge to daily tasks and assignments.
? Fluency in written and spoken English

默克雪兰诺有限公司
默克雪兰诺是总部位于德国达姆施塔特的全球医药和化工集团默克公司旗下生物制药业务分支。默克雪兰诺总部设在瑞士日内瓦，致力于发现、开发、生产和销售针对特定适应症的化学和生物的处方药。北美业务在美国和加拿大以EMD 雪兰诺的名称运营。

默克雪兰诺中国总部位于北京，拥有员工约1200人，业务遍及全国。目前，默克雪兰诺在中国经营9个领域18种药品，在未来几年里，还将上市多种新药。