About the Role
The Head of Operations will play a crucial role in
partnering engineering during the project and in developing, establishing and
managing new insulin manufacturing facility in China. This position requires a
strategic thinker with strong project and operational expertise in biologics
manufacturing, particularly in the Chinese market. This position will be a
critical interface to external regulatory and government bodies. The Operations
Head will represent both the project and in official capacities. This role
involves building and maintaining relationships with Chinese authorities,
effectively communicating project progress and ensuring compliance with local
regulations.
Key Responsibilities
China-Specific Operational Strategy and Project Leadership
Develop and implement a future-oriented, highly efficient
operational concept
Implement training concepts to local Chinese operational
workforce
Drive culture of continuous innovation and technological
advancement.
Engineering Partnership
Partner closely with engineering functions to ensure
operational expertise is integrated throughout the program.
Establish and deliver user requirements for insulin products
specific to the Chinese market and manufacturing unit.
Digitalization
Implement sustainable concepts based on global digital
directions
Spearhead the design of operational processes based on fully
digitalized systems, aligning with China's rapid technological advancements and
digital transformation initiatives.
Regulatory Compliance and Stakeholder Management
Ensure seamless implementation of biologics manufacturing
processes, cGMP requirements, and quality standards that meet both
international and Chinese regulatory expectations
Lead and contribute to authority interactions and
submissions related to the China site
Collaborate with local stakeholders
Qualifications
Master's degree or PhD in Chemical Engineering,
Biotechnology, Bioengineering, or related field from a reputable institution
(Chinese or international)
10+ years of experience in Biologics DS manufacturing, with
significant exposure to the Chinese pharmaceutical industry
Proven experience in cGMP operations & project execution
within the Chinese regulatory framework
In-depth knowledge of Chinese cGMP and international
regulatory requirements for biologics manufacturing
Technical expertise in biotech upstream and/or downstream
manufacturing of biologics
Demonstrated ability to build and lead high-performing teams
in a Chinese cultural context.
Strong skills in organization design, change management,
talent management, and strategic workforce planning, with an emphasis on
Chinese labor practices and cultural norms
Excellent leadership, communication, and teamwork skills
Intercultural experience, especially within China and
between China and global teams
Fluency in English and Mandarin Chinese (both written and
spoken) is required
Further Preferred Qualifications
Experience working with Chinese government bodies and
regulatory agencies in the pharmaceutical sector.
Knowledge of local Chinese business practices, etiquette,
and networking (guanxi).
Familiarity with Chinese labor laws and HR practices in the
pharmaceutical industry.
FA Talent(北京仕邦達人力資源服務有限公司)成立于2017年,原先是FESCO Adecco外企德科旗下專業招聘品牌。2023年,緊隨德科集團全球戰略的推進,FA Talent加入德科集團旗下人力資源管理咨詢品牌LHH FESCO,成為LHH FESCO四大業務線之一——招聘解決方案的重要成員。 FA Talent已在上海、北京、廣州、深圳、蘇州、西安等地設立辦事處,匯聚200余名專業顧問,憑借資深的顧問團隊、豐富的人才儲備、標準高效的項目流程及遍布全國的服務網絡,為生命科學、智能制造、快消零售、金融服務、汽車新能源等領域客戶提供中高端人才甄選、招聘流程外包等全方位人才獲取解決方案。我們自主研發搭建的智能人才招聘生態體系,覆蓋企業端到人才端全鏈路需求,實現人才聚合與互聯,提高用戶體驗同時提升業務效率。FA Talent始終秉承“聚英才,薦未來”的使命,拓展我們服務的深度與廣度,以堅實、高效的人才招聘解決方案,搭建企業與人才間的橋梁,做企業的招聘專家。