Overview

This role ensures and promotes compliance through external auditing of HCATS’ suppliers, vendors,  laboratory services providers, manufacturers for the Allendale, NJ and Mountain View, CA sites based on HCATS’ procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.

 

The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for HCATS and management of the Approved Supplier List.  The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites.

 

Essential Functions and Responsibilities

• Develop and maintain a risk-based external auditing program for HCATS harmonized across all sites.


• Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all HCATS facilities to ensure complete profile.


• Management of ASL to add suppliers and maintain approval status of all suppliers as needed.


• Based on ASL status, conduct reviews and perform audits to qualify each supplier used.


• Prepare external audit schedule and conduct audits per the schedule.


• Prepare and complete audit reports and communicate audit information to cross functional teams within HCATS and supplier within a timely manner.


• Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures.


• Track audit findings for suppliers to completion and ensure timely closure of audit reports.


• Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity.


• Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers.


• Maintain audit files and ensure all files are properly archived.


• Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed.


• Ensure that Quality Agreements are generated and enforced at each supplier.


• Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs.


• Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.

Qualifications

• Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry.


• Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences.


• Certified Auditor or Lead Auditor credentials required.


• Experience with auditing raw materials/excipients, components, and analytical and micro laboratories. 


• Multi-disciplinary knowledge across GxP functional areas.


• Proven ability to identify, collaborate, and resolve supplier related compliance issues.


• In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,


• EU and PMDA regulations knowledge and associated guidelines are a plus.


• Understanding of the manufacture and testing of cellular and gene therapies is desirable.


• Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation.


• Experience in Quality Assurance, including the ability to identify and resolve compliance issues.


• Sound knowledge of aseptic processing and supporting technologies.


• Travel required (approx. 50%)