ProKidney
Senior Director, Quality Control
Winston-Salem, North Carolina, United States · Director
Sponsorship not specifiedDetected 1 day ago
Project ManagementExcelSupply ChainControlsGMPLeadershipCommunicationMentoringMicrosoft Office
About the role
- Plans and assigns duties to meet departmental and organizational objectives.
Responsibilities
- Supports the design and execution of the environmental monitoring and sterility assurance programs for GMP manufacturing operations.
- Supports development of QC tests and analytical methods that support production, including design support
- Validates analytical test methods for raw materials and finished goods
- Responsible for developing and delivering training materials to ensure that all QC employees' operational, scientific, and analytical training is conducted as needed to ensure that the group is entirely and accurately trained on time for all QC activities.
- Provide support in resolving issues to meet project goals and deliverables.
- Responsible for ensuring the appropriate stability programs are initiated and completed to support product development and customer requirements.
- Leads and participates in projects within the organization's objectives and project timelines and participates in cross-functional projects as the quality control subject matter expert.
- Hires, manages, and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provides guidance and direction to staff, including appropriate training, mentoring, and development of staff.
Requirements
- Knowledge: Strong knowledge of cGMP manufacturing and testing requirements for human cells, including 21 CFR 210, 211, 820, and 1271
- Strong knowledge of cGMP manufacturing and testing requirements for human cells, including 21 CFR 210, 211, 820, and 1271
- Strong scientific background and experience with cellular therapies across a broad range of cell types and disease treatments (adult-derived cells, stem cells, immune cells. allogeneic, autologous, etc.)
- Education/Training: Bachelor's degree in biology, biochemistry, immunology, molecular and cellular biology, or a related scientific discipline required. Advanced degree or Ph.D. in a scientific or technical discipline preferred.
- EudraLex
- and ICH guidelines. Understanding of analytical method qualification and validation per USP, EP, and ICH guidelines.
- Skills: Advanced root cause investigation, troubleshooting, laboratory data evaluation, risk management, project leadership, communication, relationship-building, and team leadership skills. Proficiency with Microsoft Word, PowerPoint, and Excel required.
- ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Nice to have
- Bachelor's degree in biology, biochemistry, immunology, molecular and cellular biology, or a related scientific discipline required.
- Advanced degree or Ph.D. in a scientific or technical discipline preferred.
- 10+ years of experience in a GMP-regulated biopharmaceutical environment, including 10+ years in a management or leadership role.
- Experience in biologics or cell therapy preferred.
Skills
- Proficiency with Microsoft Word, PowerPoint, and Excel required.
- Certifications/Licenses: N/A
- Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
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.