Senior Validation Leader GxP, CSV & Quality Systems

ProKidney; Winston-Salem (NC); On-site; USD 100,000 - 140,000; Full time

Job summary

A biopharmaceutical company in Winston-Salem is seeking a Sr. Manager of Validation to lead the Qualification and Validation teams. Responsibilities include driving performance, ensuring regulatory compliance, and supporting validation initiatives. Candidates should have a Bachelor’s degree in Life Sciences or Engineering, over 10 years of relevant experience, and at least 3 years in leadership roles. This position emphasizes strong technical writing, project management skills, and knowledge of GxPs. Competitive compensation and benefits are offered.

Qualifications

• 10+ years in relevant work experience.
• 8+ years in biopharmaceutical or related engineering roles.
• At least 3 years in a leadership position.

Responsibilities

• Lead the qualification and validation teams.
• Ensure adequate resources for operational objectives.
• Interact with senior management on multi-department projects.
• Drive performance and continuous improvement initiatives.

Skills

Leadership

Data integrity

Technical writing

Project management

GxPs

Regulatory compliance

Education

Bachelor’s degree in Life Sciences or Engineering

Tools

Calibration and maintenance management software

Electronic document management systems

Job description

A biopharmaceutical company in Winston-Salem is seeking a Sr. Manager of Validation to lead the Qualification and Validation teams. Responsibilities include driving performance, ensuring regulatory compliance, and supporting validation initiatives. Candidates should have a Bachelor’s degree in Life Sciences or Engineering, over 10 years of relevant experience, and at least 3 years in leadership roles. This position emphasizes strong technical writing, project management skills, and knowledge of GxPs. Competitive compensation and benefits are offered.