Chief Quality Officer

About Genscript

Genscript Biotech Corporation (Stock Code: 1548.Hk) Is A Global Biotechnology Group. Founded In 2002, Genscript Has An Established Global Presence Across North America, Europe, The Greater China, And Asia Pacific. Genscript'S Businesses Encompass Four Major Categories Based On Its Leading Gene Synthesis Technology, Including Operation As A Life Science Cro, Enzyme And Synthetic Biology Products, Biologics Development And Manufacturing, And Cell Therapy.

Genscript Is Committed To Striving Towards Its Vision Of Being The Most Reliable Biotech Company In The World To Make Humans And Nature Healthier Through Biotechnology.

About Probio

Probio Proactively Provides End-To-End Cdmo Service From Drug Discovery To Commercialization With Proactive Strategies, Professional Solutions And Efficient Processes In Cell And Gene Therapy, Vaccine, Biologics Discovery And Antibody Protein Drug To Accelerate Drug Development For Customers. Probio’S Total Cell And Gene Therapy Solution Covers Cmc Of Plasmid And Virus For Ind Filing As Well As Clinical Manufacturing And Commercial Manufacturing.

Job Scope:

The Chief Quality Officer (CQO) will lead the Global quality assurance, regulatory compliance, and risk management functions. ensuring that products, processes, and operations meet regulatory standards and company quality objectives. have accountability for understanding, coordinating and measuring performance of internal and external quality and safety requirements and will provide leadership in strengthening a quality culture where everyone is engaged and respected.

Essential Responsibilities:

• Develop and implement the foundational strategy and change management that is necessary to realize continuous improvement and eliminate process variations
• Work collaboratively across the enterprise and externally to strengthen and reinforce a culture of quality, safety and value across ProBio.
• Build and lead a multidisciplinary quality and safety organization that transcends existing units and reinforces a consistent approach to quality and safety.
• Create an environment that fosters innovation and performance, supporting the implementation of programs that continuously strengthen the customer experience. Actively implement innovative ideas to redefine, measure and improve quality.
• Build and maintain strong client relationships as the key quality interface, ensuring transparency, trust, and responsiveness.
• Direct manage Quality Assurance, Quality Control, and Compliance teams across global manufacturing and testing sites.
• Lead in developing, directing and coordinating innovative quality and outcomes management initiatives across ProBio that incorporate national best practices, drive down variation, decrease costs and create efficiencies.
• Provides an inclusive workplace that fosters the development of others, facilitates cooperation and teamwork, and supports constructive resolution of conflicts.
• Encourages workforce engagement by building a commitment to excellence and by promoting the organization's vision internally and externally.
• Exceeds organizational goals and customer expectations. Makes decisions that produce high-quality results by applying technical knowledge, analyzing problems, and calculating risks.
• Holds self and others accountable for measurable high-quality, timely, and cost-effective results.

Qualifications:

• Over 15+ years of progressive experience in Quality Management within a CDMO, Biologics, Cell & Gene Therapy, or Pharmaceutical environment.
• Proven track record of leading global quality and compliance operations in a multi-site organization.
• Deep knowledge of FDA, EMA, ICH, and global regulatory requirements, including cGMP and Quality Systems.
• Demonstrated success in regulatory inspections and client audits.
• Strong leadership, communication, and influencing skills — capable of engaging both internal teams and external partners.
• Bachelor’s or advanced degree in Life Sciences, Quality, Regulatory Affairs, or related field.
• Certifications such as ASQ, Six Sigma, or ISO Lead Auditor preferred.

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GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.