Quality Compliance Specialist 3

The Quality Compliance Specialist 3 is a key member of the ProKidney Quality team, contributing to the organization’s success by managing and executing auditing programs (including vendor audits, internal audits, and ProKidney audits) and Management of Change (MOC) activities. This role is vital in ensuring regulatory compliance with current Good Manufacturing Practices (cGMP) and supporting the development and maintenance of quality systems aligned with both global and internal requirements.

The successful candidate will have a deep understanding of global cGMP regulations and be responsible for providing oversight and guidance on quality compliance activities supporting ProKidney products across manufacturing and clinical study phases.

Essential Duties and Responsibilities:

1. Vendor Management Program:

• Maintain and manage the Approved Vendor List (AVL).
• Oversee and update the Vendor Audit Schedule.
• Execute vendor audits/assessments, ensure timely follow-up on any observations or concerns.
• Author and manage Quality Agreements with approved vendors.
• Lead investigations stemming from the Vendor Complaint and Vendor Change Notification program, ensuring that all potential impacts on ProKidney’s Quality Management System are thoroughly documented and addressed.
• Act as the point of contact for vendor communications related to quality and compliance matters.

1. Internal Audit Program:

• Manage and maintain the Internal Audit Schedule.
• Plan and execute internal audits, ensuring they align with procedural requirements.
• Review, approve, and track internal audit documentation, ensuring proper follow-up and execution of audit responses.
• Communicate effectively with GMP stakeholders regarding audit findings and actions.

1. External Audits of ProKidney:

• Provide support during GMP audits of ProKidney.
• Assist in developing and executing responses to audit findings, including necessary documentation.

1. Management of Change (MOC) Program:

• Support GMP stakeholders in the identification, establishment, execution, and completion of MOC documentation, including impact assessments and action plans.
• Act as the administrator for MOC documentation.

1. Additional Responsibilities:

• Provide technical expertise to support quality decisions and resolve quality issues.
• Collaborate with site leaders and stakeholders to drive continuous improvement in quality compliance activities.
• Support cross-functional teams in project completion, quality issue resolution, and implementation of quality systems improvements.
• Influence peers to ensure compliance with internal SOPs and global regulations.
• Identify and implement continuous improvement opportunities across functional areas such as manufacturing, facilities, and Quality Control.
• Maintain GMP departmental databases, ensuring accurate data tracking and follow-up.
• Identify and communicate compliance risks, providing action plans for mitigation.
• Escalate critical quality issues to senior management as needed.
• Stay current on industry trends, standards, and best practices as they relate to cGxP.
• Perform other duties as assigned by the Manager, Quality Compliance.

Knowledge, Skills, and Abilities:

• Strong understanding of cGMP regulations, including 21 CFR Parts 210, 211, 11, and Eudralex.
• Familiarity with the full scope of manufacturing, packaging, regulatory affairs, compliance, clinical, and quality assurance requirements for biological and medical product manufacturing.
• Exceptional attention to detail and organizational skills.
• Ability to interpret and apply technical documents, regulations, and industry standards.
• Strong report-writing, business correspondence, and procedure development skills.
• Ability to analyze complex data, define problems, and draw sound conclusions.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
• Excellent decision-making skills and sound judgment in high-pressure situations.

Education and Experience:

• Bachelor’s degree in a scientific discipline or equivalent experience.
• Minimum of 4–6 years of relevant experience in a regulated medical, pharmaceutical, or biotechnology environment with a strong focus on cGMP compliance.
• Demonstrated experience in auditing (vendor, internal, and external audits) and Management of Change (MOC)
• Experience in leading and executing quality assurance or compliance initiatives, such as audit programs, quality agreements, and corrective actions.
• Solid understanding of regulatory requirements (e.g., FDA, EU, ICH, ISO) and industry guidelines.
• Experience supporting or participating in regulatory inspections and understanding the inspection process.
• Prior experience working with cross-functional teams (e.g., manufacturing, quality control, clinical, regulatory) is highly preferred.

• Auditor certification (e.g., Certified Quality Auditor (CQA)) is a plus.

The position reports directly to the Manager, Quality Compliance.