ProKidney
Associate Director, Validation
Winston-Salem, North Carolina, United States · Director
Work authorization requiredDetected 26 days ago
CybersecurityGMPFDA RegulatoryLeadershipCommunicationProblem SolvingWritingOSHA
About the role
- Serve as a member on project steering, value stream and quality systems performance teams.
Responsibilities
- Regularly interacts with senior management or executives on multi-department projects and challenges. Able to build coalitions for change.
- Identify areas to drive down operations costs and improve project delivery efficiency. Develop specific investment strategies to realize these savings
- Hands on troubleshooting and problem solving at the Gemba in support of engineering team members and operations
- Develop and lead small and medium sized continuous improvement projects, remain involved in projects led by staff members
- Effective delegation and building confidence and competence within direct reports
- Drive engagement in the technical and personal development of the Validation team and members
- Develops strong relationships with partners (QA, Mfg., etc.) and cultivates these with all team members
- Knowledge of electronic document management systems
- Strong technical writing skills for qualification documents, SOPs, and work instructions
- Ability to manage multiple projects simultaneously with minimal supervision
Requirements
- Bachelor's degree.
- A minimum of 10 years of experience in a biopharmaceutical or related environment in an engineering or quality related role, with at least 5 years in a leadership role
- Strong understanding of Validation Lifecycle (GAMP 5) principles
- Experience with calibration and maintenance management software
- Experience with data integrity practices and compliance
- Ability to adapt to changing priorities in a deadline-oriented environment
- Significant hands-on experience and regulatory expectations knowledge with controls, automation and computer system validation.
Nice to have
- Preferred Fields of Study: Life Sciences or Engineering
Compensation
- Direct support to OST head or lead annual OPEX budget for Validation department
Visa & Work Authorization
- Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
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This listing is sourced directly from ProKidney's careers page and normalized into a canonical job model.