Manager, QA Vendor Management

The Manager of Quality Vendor Management plays a critical role in ProKidney’s Quality team, ensuring the effective oversight and progression of our vendor program including vendor audits, assessments, Quality Agreements, Supplier Corrective Action Requests (SCAR) and the management of ProKidney’s Approved Supplier List (AVL). This role will also provide support as needed for various Quality Management Systems as needed.

 

This position requires an understanding of global cGMP regulations, supporting the development, implementation, and maintenance of our Quality Vendor Management program. The role is accountable for overseeing and guiding the quality compliance components of the vendor program to ensure the manufacture and clinical study of ProKidney products meet global and internal requirements.

 

Essential Duties and Responsibilities:

·         Team Management:

• May lead and manage a team of Quality associates and/or contractor/consultant.
• Coordinate, delegate, and verify compliant execution of team

 

·         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
• Oversee and execute vendor audits and assessments, reviewing and approving audit
• Ensure appropriate follow-up actions are taken with vendors for any observations or
• Manage the establishment and oversight of Quality Agreements with approved
• Oversee Vendor Complaint and Vendor Change Notification programs, ensuring impacts to the Quality Management System (QMS) are documented and
• Communicate with vendors as necessary to ensure smooth audit and compliance
• Participate as a lead auditor in vendor
• Support back-room activities during GMP audits of
• Support the establishment, documentation, and execution of audit
• Communicate with auditors or auditing organizations as needed.

 

·         Additional Responsibilities:

• Report on metrics related to Vendor Management
• Support process improvement initiatives based on metric
• Provide technical expertise for quality
• Collaborate closely with site leaders and other key stakeholders to ensure daily execution and continuous improvement of the Vendor Management activities.
• Review and approve various Quality documentation to ensure it meets established procedures and regulatory requirements.
• Address quality issues and implement quality system
• Influence peers and stakeholders to ensure compliance with internal SOPs and global regulations.
• Review and update GMP system procedures in alignment with regulatory and company standards.
• Identify, communicate, and mitigate compliance
• Collaborate with internal departments on quality strategy and regulatory
• Escalate critical quality issues to senior management when
• Maintain effective cross-functional communication to support quality activities, while ensuring independence and autonomy.
• Stay current with industry trends and cGxP
  
  

·         Other Responsibilities:

• Perform other duties as assigned by management as required.

 

Knowledge, Skills, and Abilities:

• Strong understanding of GMPs and vendor management expectations for US FDA and/or EU regulated companies.
• Strong attention to details.
• Ability to interpret and apply technical writing, regulations, and
• Proficiency in writing reports, business correspondence, and
• Ability to present information and respond to questions from managers and
• 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.

 

Education and Experience:

• Bachelor’s degree in a science or engineering - related field or equivalent
• 5+ years of applicable experience in a regulated pharmaceutical or biotech
• Autologous Cell Therapy experience is a plus.
• Knowledge of industry guidelines (cGMP, FDA, EU, ICH, ISO) and regulatory inspections.
• High ethical standards, transparency, and

 

This position reports directly to the Sr. Director, Quality Systems & Compliance.