Senior Associate Director, Validation & Quality Systems

ProKidney Corp.; Winston-Salem (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

A biopharmaceutical company is seeking an Associate Director of Validation to lead the Qualification and Validation teams. Candidates must have a Bachelor’s degree in Life Sciences or Engineering, with a minimum of 10 years of experience in a relevant field and at least 5 years in a leadership role. Responsibilities include directing validation efforts, supporting regulatory inspections, and driving continuous improvement projects. The ideal candidate will have strong knowledge of GxPs, effective communication skills, and the ability to manage multiple projects simultaneously.

Qualifications

• Minimum of 10 years in biopharmaceutical or related environment.
• At least 5 years in a leadership role.
• Expert knowledge of GxPs and Data Integrity requirements.
• Strong understanding of Validation Lifecycle (GAMP 5).
• Detail-oriented with excellent communication abilities.

Responsibilities

• Provide leadership and direction to Validation team.
• Ensure adequate resourcing to accomplish site objectives.
• Represent Validation during regulatory inspections.
• Identify areas to reduce operations costs and improve efficiency.
• Develop and lead continuous improvement projects.

Skills

GxPs, GAMP, CFRs/Annex 11

Technical writing

Leadership

Project management

Data integrity practices

Education

Bachelor’s degree in Life Sciences or Engineering

Tools

Calibration management software

Electronic document management systems

Job description

A biopharmaceutical company is seeking an Associate Director of Validation to lead the Qualification and Validation teams. Candidates must have a Bachelor’s degree in Life Sciences or Engineering, with a minimum of 10 years of experience in a relevant field and at least 5 years in a leadership role. Responsibilities include directing validation efforts, supporting regulatory inspections, and driving continuous improvement projects. The ideal candidate will have strong knowledge of GxPs, effective communication skills, and the ability to manage multiple projects simultaneously.