Job Description

The Quality Assurance On-The-Floor (OTF) Manager will lead and develop the QA On-The-Floor program for ProKidney. Reporting to the Director, Quality Assurance, this role will be based at our cGMP Manufacturing sites and will directly support the expanding CMC development programs. The Manager will efficiently manage, plan, organize, and direct QA floor support scheduling during manufacturing activities. Strong decision-making skills and independent thinking are crucial for success in this role, which involves close collaboration with Manufacturing, Quality Control, Supply Chain, and Facility teams.

Essential Duties & Responsibilities:

• Lead the team responsible for on-the-floor support of manufacturing, including reviewing documentation and providing real-time support during changeovers and other manufacturing issues.
• Develop direct reports and ensure completion of required training.
• Review and approve activities performed by direct reports.
• Delegate activities to support team responsibilities.
• Ensure all on-the-floor support personnel are gowning qualified at all times.
• Oversee and generate quality on-the-floor support schedules aligned with the manufacturing schedule.
• Execute floor support activities, including routine walkthroughs of manufacturing suites, partnering with manufacturing on suite maintenance, implementing Quality best practices, and troubleshooting issues as they arise.
• Perform real-time quality batch record review and identify potential deviations requiring reporting.
• Document observations identified during manufacturing runs and escalate or resolve issues as appropriate.
• Review documentation related to GMP activities such as forms, logbooks, testing documentation, Building Management System alarms, equipment alarms/cleaning, and kitting processes.
• Ensure all quarantined materials are stored appropriately post-manufacturing activities.

Additional Responsibilities:

• Communicate significant Quality issues to key stakeholders promptly.
• Interact frequently with direct manager, subordinates, and cross-functional peers to align on quality decisions.
• Make or support quality decisions impacting operations, ensuring appropriate escalation and resolution of complex issues.
• Identify risks and communicate quality and GMP process/system gaps.
• Review and approve facility alarms, work order requests, and return-to-service documentation.
• Support, review, and approve Deviations and Change Controls associated with operational activities, batch records, or manufacturing improvements.
• Train new employees on Batch Record Review, Floor Support activities, and Room Release processes.
• Collaborate effectively in a dynamic, cross-functional matrix environment, managing multiple projects in a fast-paced setting.
• Author and review SOPs and policies to ensure compliance with regulations and cGMP operations.
• Participate in quality-focused teams across ProKidney’s functions.
• Support internal audits to ensure adherence to cGMP, SOPs, and manufacturing documentation.
• Establish and follow procedures for clear and accurate documentation of equipment operation, process instructions, and data.
• Perform other duties as assigned by manager.

Education And Experience:

• Bachelor’s degree in applied science or a related field.
• 5+ years of relevant experience in Quality Assurance or Quality Control, ideally within cGMP aseptic manufacturing operations.
• Strong organizational, analytical, and time management skills.
• Ability to work well in a team environment with a positive attitude and willingness to assist other areas of the organization.
• Excellent verbal and written communication skills with a strong focus on attention to detail.
• Ability to handle multiple tasks simultaneously while maintaining a strong attention to detail.
• Demonstrated working knowledge of FDA, EU, and ICH Regulatory requirements and guidelines.
• Physical ability to perform frequent tasks requiring strength and mobility; flexible scheduling may be required.
• Any equivalent combination of education, experience, and training may substitute.

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.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.