Manager, Quality Compliance

Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients' lives. Our technology is designed to treat diseased kidneys using a patient's own cells and may prevent or delay dialysis or transplant.

The Manager of Quality Compliance plays a critical role in ProKidney's Quality team, ensuring the effective oversight and progression of our auditing programs (including vendor audits/assessments, internal audits, and audits of ProKidney) and Management of Change activities to support regulatory compliance with cGMP regulations.

This position requires a strong understanding of global cGMP regulations, supporting the development, implementation, and maintenance of auditing and Management of Change processes at ProKidney. The role is accountable for overseeing and guiding Quality Compliance components to ensure the manufacture and clinical study of ProKidney products meet global and internal regulatory requirements.

Essential Duties and Responsibilities:

• Team Management:
• Lead and manage a team of technical experts in Quality Compliance.
• Coordinate, delegate, and verify compliant execution of team activities.
• Support the development and oversight of Quality Compliance personnel, including managing their time and responsibilities.
• Vendor Auditing & Assessments:
• Implement, maintain, and approve ProKidney procedures and documentation for vendor audits and assessments to ensure GMP materials and services meet ProKidney requirements.
• Establish and maintain the Approved Vendor List and Vendor Audit Schedule.
• Oversee and execute vendor audits and assessments, reviewing and approving audit documentation.
• Ensure appropriate follow-up actions are taken with vendors for any observations or concerns.
• Manage the establishment and oversight of Quality Agreements with approved vendors.
• Oversee Vendor Complaint and Vendor Change Notification programs, ensuring impacts to the Quality Management System (QMS) are documented and addressed.
• Communicate with vendors as necessary to ensure smooth audit and compliance processes.
• Internal Audits:
• Implement, maintain, and approve ProKidney procedures and documentation for internal audits of the QMS.
• Establish and maintain the Internal Audit Schedule.
• Perform and oversee internal audits, reviewing and approving audit documentation.
• Ensure internal audit responses are properly documented and executed in accordance with procedural requirements.
• Communicate with GMP stakeholders as necessary.
• External Audits:
• Participate as a leader in audit rooms during GMP audits of ProKidney.
• Lead back-room activities during GMP audits of ProKidney.
• Lead the establishment, documentation, and execution of audit responses.
• Communicate with auditors or auditing organizations as needed.
• Management of Change Program:
• Implement, maintain, and approve procedures and documentation for the Management of Change (MOC) program.
• Support GMP stakeholders in identifying change control documentation, including creating, executing, and completing impact assessments and action items.
• Review and approve MOC documentation.
• Additional Responsibilities:
• Report metrics related to Vendor Management, Internal Audits, and MOC activities.
• Support process improvement initiatives based on metric reviews.
• Provide technical expertise for quality decisions.
• Collaborate closely with site leaders and other key stakeholders to ensure daily execution and continuous improvement of Quality Compliance activities.
• Review and approve Quality Compliance documentation to ensure it meets established procedures and regulatory requirements.
• Lead cross-functional teams to address quality issues and implement quality system improvements.
• Influence peers and stakeholders to ensure compliance with internal SOPs and global regulations.
• Identify and support the implementation of continuous improvement opportunities across departments (e.g., Manufacturing, Facilities, QC).
• Maintain GMP databases and ensure consistent data tracking and follow-up.
• Review and update GMP system procedures in alignment with regulatory and company standards.
• Identify, communicate, and mitigate compliance risks.
• Provide cGxP compliance consultation, training, and services to improve data integrity and credibility.
• Collaborate with internal departments on quality strategy and regulatory requirements.
• Escalate critical quality issues to senior management when necessary.
• Maintain effective cross-functional communication to support quality activities, while ensuring independence and autonomy.
• Stay current with industry trends and cGxP standards.
• Other Responsibilities:
• Perform other duties as assigned by the Director, CMC Regulatory Compliance.

Knowledge, Skills, and Abilities:

• Strong understanding of laboratory, manufacturing, packaging, regulatory affairs, compliance, clinical, and quality assurance requirements for biological and product manufacturing.
• Excellent leadership and people management skills.
• Strong attention to detail and analytical skills.
• Ability to interpret and apply technical writing, regulations, and instructions.
• Proficiency in writing reports, business correspondence, and procedures.
• Ability to present information and respond to questions from managers and colleagues.
• Strong problem-solving skills, including the ability to collect data, analyze facts, and draw valid conclusions.
• Proficient in MS Office Suite (Word, Excel, PowerPoint).
• Solid judgment and decision-making skills in complex situations.

Education and Experience:

• Bachelor's degree in a science-related field or equivalent experience.
• 5+ years of applicable experience in a regulated medical environment.
• Extensive knowledge of industry guidelines (cGMP, validations/qualifications, FDA, EU, ICH, ISO) and regulatory inspections.
• High ethical standards, transparency, and confidentiality.

The position reports directly to the Director, CMC Regulatory Compliance (Quality Assurance).

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.