Job Description

Position Summary:

The Chief Quality Officer (CQO) will lead ProBio’s global Quality Assurance, Regulatory Compliance, and Risk Management functions. This role is accountable for ensuring that all products, processes, and operations consistently meet regulatory requirements and align with the company’s quality objectives. The CQO will be responsible for overseeing internal and external quality and safety performance, driving a culture of continuous improvement, and fostering an organization-wide commitment to excellence, collaboration, and respect.

Key Responsibilities:

• Develop and execute a comprehensive quality strategy and change management plan to drive continuous improvement and eliminate process variability.
• Collaborate across global functions and external partners to strengthen a culture of quality, safety, and operational excellence across ProBio.
• Build and lead a multidisciplinary Quality and Safety organization that unifies standards and promotes a consistent approach across all business units.
• Create an environment that encourages innovation and performance, implementing programs that enhance the customer experience and drive measurable improvements in quality.
• Serve as the key quality interface for clients, fostering strong relationships built on transparency, trust, and responsiveness.
• Directly oversee Quality Assurance, Quality Control, and Compliance teams across global manufacturing and testing sites.
• Lead the development and implementation of innovative quality and outcomes management initiatives aligned with industry best practices to reduce variation, improve efficiency, and optimize costs.
• Promote an inclusive and engaging workplace that supports professional development, collaboration, and constructive conflict resolution.
• Inspire workforce engagement through a shared commitment to excellence and by championing the organization’s vision both internally and externally.
• Demonstrate strong decision-making and accountability to achieve measurable, high-quality, timely, and cost-effective results.

Qualifications:

• 15+ years of progressive leadership experience in Quality Management within CDMO, Biologics, Cell & Gene Therapy, or Pharmaceutical industries.
• Proven track record of leading global quality and compliance operations across multi-site organizations.
• Deep understanding of FDA, EMA, ICH, and other global regulatory standards, including cGMP and Quality Management Systems.
• Demonstrated success in managing regulatory inspections and client audits.
• Exceptional leadership, communication, and influencing skills with the ability to engage both internal teams and external stakeholders.
• Bachelor’s or advanced degree in Life Sciences, Quality, Regulatory Affairs, or related disciplines.
• Professional certifications such as ASQ, Six Sigma, or ISO Lead Auditor preferred.
• Prefer the candidate who can speak Mandarin and English

Job Tags

Similar Jobs