Chief Quality Officer

GenScript/ProBio

93d

About The Position

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. The CQO will 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.

Requirements

• 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.

Nice To Haves

• Certifications such as ASQ, Six Sigma, or ISO Lead Auditor preferred.

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.
• Directly 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.
• Provide an inclusive workplace that fosters the development of others, facilitates cooperation and teamwork, and supports constructive resolution of conflicts.
• Encourage workforce engagement by building a commitment to excellence and by promoting the organization's vision internally and externally.
• Exceed organizational goals and customer expectations. Make decisions that produce high-quality results by applying technical knowledge, analyzing problems, and calculating risks.
• Hold self and others accountable for measurable high-quality, timely, and cost-effective results.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees