Site Quality Head 工厂质量负责人

Posted 06 Feb 2024

Nantong, Jiangsu - China

Req Id 271302

 

与我们携手施展你的超能力!

探索未知、打破壁垒、勇于发现,你准备好了吗?你有宏图大志正待实现,我们同样雄心勃勃。我们遍布全球的员工热爱科技创新,以医药健康、生命科学和电子科技领域的解决方案,切实改善人类生活。我们怀揣远大梦想,热忱关爱员工、客户、患者和人类居住的这颗星球。因此我们一直在寻找永葆好奇心的你,与我们一路同行、敢想敢做,把不可能变为可能! 

在医药健康领域,我们团结一致,齐心为病患,帮助孕育、改善和延长生命。这是我们的目标,也是我们每天不懈努力的原因。默克在肿瘤、神经变性疾病和辅助生殖等领域不断开发创新药物、智能设备与创新科技。我们的团队遍布全球六大洲,在共同的理念与好奇心驱动下,我们全力以赴地为处于生命各个阶段的患者提供拥抱新生活的机会。加入我们,成为这个多元、包容、灵活工作文化的一份子,并获得在全球范围内的个人职业发展机会。

 


 

Your Role:

Your main responsibility is leadership and efficient operation of the Quality function of pharma manufacturing site.  You are accountable for the quality oversight of the manufacturing site operations in compliance with GMP requirements and regulations in force, for the operational planning and cost, the performance of site Quality organization, employee development and taking responsibility as Qualified Person according to the Chinese regulation.

 

You set and assure adequacy of all quality systems and process, assures that all materials and products meet the registration requirement and specification. You are responsible for decisions made within the intent of cGMP, company, customer, and regulatory requirements. You provide overall leadership responsibility for the Quality Organization (team of 50-100 people) and is a member of the Site Leadership Team assuming responsibility for the leadership and governance at the site. You set the vision and establishes priorities for the Quality function in alignment with the strategic direction and focus for global Quality and site and adjusting priorities as necessary/in accordance with shifting business needs. You are accountable for effectively leading, driving and managing change for the functional area. You maintain effective internal auditing program to provide assurance that the site maintains a compliant state for internal and Health Authority audit. You implements/supports business process for continuous improvements in all areas of site operations. You collaborate with other stakeholders from Site Leadership, other quality leaders, Regulatory Affairs and Corporate function to assists in the implementation, continuous improvement and lifecycle management of implemented GMP policies and quality management system, implementing, updating the system GMP documents and standards. As Qualified Person, you are responsible for disposition process, detect risks of non-compliance and triggers preventive actions.

 

 

Who you are:

  • Minimum of a Bachelor's of Pharmaceutical or related.
  • Minimum of 10 years experience as a Quality Manager Leadership of a pharmaceutical &/or closely related equivalent.
  • Fluent in English.
  • Several years of distinctive experience in a leadership position managing a team.
  • Experience with managing regulatory agency inspections.
  • Comprehensive knowledge of global GMP regulatory requirements and hands-on experience with overseeing GMP operations in a commercial manufacturing facility.
  • Demonstrated superior communication skills (verbal, written and presentation), influencing, interpersonal relation, collaboration, problem solving, effective facilitation and change management skills.
  • Shows resilience and effective performance even in the face of significant obstacles and consistent resilience from stakeholders.
  • Strong team building, interpersonal/negotiation skills including conflict resolution to complex problem with increasing legal and regulatory complexity.
  • Highly ethical and transparent, with professional sensitivity and care for confidentiality.
  • Work cross functionally to ensure the strategic and operational plans are delivered with excellent communication and strong presentation skills.
  • Strong business intelligence, analytics, reporting and visualization, technical expertise.
  • Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and multiple internal and external stakeholders.


我们能够提供:我们对未知充满好奇,我们的员工有着多样化的背景、多维度的视角和个性化的经历。作为一家前沿科技企业,我们欣赏全方位的多元性,坚信这能驱动卓越和创新,从而强化我们“科技先锋”的底色。同时我们致力于为所有员工提供机会和资源,支持他们按各自的节奏充分成长和发展。加入我们,共建充满包容性和归属感的企业文化,让每一位志同道合的伙伴能够施展自己的超能力,共同推动人类迈向进步的未来!

 

立即申请,成为我们多元化团队的一员!


US Equal Employment Opportunities

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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