Job Overview:        

 

The Director of QA Audit is responsible for managing a team of professionals with an overall objective to strategically direct QA audit activities that provide an independent assessment (IA)   activity specifically related to Passage’s GXP programs.

 

 

 

Responsibilities:

• Directs the external and audit programs for Passage Bio.  Includes qualification, routine, and for cause audits of external service providers.
• Guides the internal audit program to assess the status of the company’s current Quality Systems procedures and processes, according to regulatory guidelines and compliance requirements. Identifies gaps and develops plan for implementation of ongoing process improvement.
• Works with other quality staff and internal personnel to develop risk assessment, corrective action plans, investigational plans, and root cause analysis.
• Supports regulatory submission activities from pre-IND through commercial authorization for multiple gene therapy products, collaborating with colleagues on filings, amendments and annual reports.
• Point person for any external quality interactions, including inspection-related matters.
• Create and present local audit committee reporting for QA results, as required.
• Provide day-to-day pragmatic support and guidance to the auditors on methodology-related matters by leveraging experience and using professional judgement.
• Support IA teams in regulatory matters, including review of responses to regulators and presenting directly to regulators as required.

 

 

Requirements:

• 10+ years of experience in a related role
• Bachelor’s degree or equivalent experience
• Thorough understanding of Good Clinical and Good manufacturing practices
• Experience with audit programs for cell or gene therapy programs
• Related certifications (ASQ, SQA, ISO) preferred.
• Demonstrated success in business, functional and people management.
• Consistently demonstrates clear and concise written and verbal communication.
• Demonstrated ability to remain unbiased in a diverse working environment.
• Effective negotiation skills