Senior Quality Assurance Specialist - Vendor Management

Sr. Quality Systems Vendor Management Specialist provides the direction/coordination/education/tools needed to develop and maintain an effective Quality Management System (QMS) Vendor Management Program that is compliant with ProKidney Corporation Policies and Regulatory standards.

Essential Duties & Responsibilities:

• Set Quality system requirements to suppliers, including those for services, indirect quality relevant purchases (non-BOM), and Quality System requirements for suppliers in global markets.

• Assure harmonized processes and systems are deployed to perform Qualification of suppliers' QMS to the relevant drug (where applicable) quality regulations, and accountable for their placement on the Approved Supplier List (ASL), including required Purchasing Data elements of Supplier Master File.

• Ensure proper assessment and documentation of any supplier-related controls and/or hazards within the material/product risk assessment.

• Champion and continuously improve supplier-related nonconformance management process, with emphasis on striving for excellence in true root cause analysis effective verification of prevailing CAPAs executed by suppliers.

• Manage 3rd Party Supplier Program, Certifications, Audits and CAPAs

• Support global design and administration of outsourced auditing.

• Manages all inbound supply risks including material security, quality, product safety and regulatory compliance.

• Supporting Quality Systems with the purpose to quality assure purchased items and the related production processes to projects to minimize supplier related quality failures at ProKidney.

• Supporting Process Audits at suppliers and drive suppliers to close the gaps.

• Supporting Quality Systems in keeping all part quality information accurate and updated in ProKidney systems.

• Supporting Quality Systems with data analysis as required monitoring supplier performance and project deliverables.

• Other duties as assigned by Director of Quality Systems.

Computer Skills:

• Proficiency Microsoft products including Outlook, SharePoint, Word, PowerPoint, and Excel.

• MasterControl (Other EMS System) Supplier/Audit Module experience a plus.

Education And Experience:

• Bachelor of Science degree in a scientific discipline required

• Minimum of 5 years of experience working in a GxP regulated environment required.

• Experience with conducting/participating in Audits (authorities, suppliers).

• Experience in a similar role in the biologics or pharmaceutical industry a plus.

• Certification of Supplier Quality Assurance a plus.

Knowledge, Skills, And Abilities

• Must demonstrate excellent problem-solving ability, technical writing skills, good communication skills, and teamwork.

• Knowledge of manufacturing processes and safety in GMP regulated facilities - Pharmaceutical/Medical Device/Biotechnology.

• Knowledge of manufacturing processes and safety in GMP regulated facilities.

• Must be flexible and able to adapt to company growth and evolving responsibilities.

• Ability to multi-task and manage multiple projects with shifting priorities in a fast-paced manufacturing environment.

• Demonstrate understanding of cGMP, GDP, and QMS.

• Ability to learn and understand technical aspects within documentation.

• Ability to maintain positive cross-functional and collaborative relationships.

• Ability to maintain a positive attitude and ability to perform under pressure.

• Ability to exercise judgment within defined practices and policies in performing document control functions with input from supervisor.

• Strong communication skills, including both verbal and written.

• A proven track record in Supplier Management and/or Supplier Development.