Director Quality Assurance (Audit) - Cell/Gene Therapy

Company: Passage Bio
Location: Philadelphia
Posted on: November 15, 2019

Job Description:

Job Overview: The GMP Auditor will be responsible for ensuring the quality assurance of all CMOs and internal deliverables planning and conducting quality audits in manufacturing (GMP) within designated Quality Auditing area. This role will work closely with SMEs and CMOs to assess the quality risks and compliance within the gene therapy manufacturing process.
Responsibilities:

• Manage the Quality Assurance of all activities during the production of clinical and future commercial Gene therapy products (Starting Materials, Reagents, Media and all components used in the manufacture processes).
• Assess the status of the company's current Quality Systems procedures according to regulatory guidelines and compliance requirements to identify the gaps and develop a plan for implementation.
• Author, revise and review SOPs that for technical areas and manufacturing quality.
• Develop and establish a master validation plan for the company.
• Ensure that that process validation is executed in accordance with current guidelines and meet regulatory requirements.
• Develop productive relationships with CMOs/CTOs for all products and projects.
• Review batch record documentation for disposition.
• Oversee the release process of starting materials, drug substance and all other components before use in production.
• Work with cross functional peers to meet company's deadlines.
• Support filing activities for IND and CTA-enabling to commercial programs for multiple gene therapy products.
• Ensures change controls are initiated, evaluated and implemented appropriately for all regulated changes.
• Conduct effective root cause analysis and implement corrective action and preventive action.
• Manage the Deviation and CAPA system and ensure timely closure and effectiveness of investigations and corrective and preventive actions.
• Host and support regulatory inspections.
• Review protocols, data summaries, and reports for stability studies and validation.
• Identify and communicate quality or compliance risks and participate in determination of appropriate plan to address risks.
• Collaborate with regulatory to support IND/NDA/MAA filings/amendments on CMC sections and Annual Reports.
• Assure that all manufacturing records (testing, methods, protocols, reports) are generated, approved and managed.
  Requirements:
  
  • 8+ years with BS of relevant experience in biological sciences or biotechnology industry
  • 6+ years of experience with MS degree in biological sciences or biotechnology industry
  • 3+ of experience with Gene/Cell therapy products for clinical and commercial
  • Demonstrated ability to apply comprehensive, in-depth, understanding of pharmaceutical industry regulatory compliance requirements with an emphasis on GMP/GLP/GCP related issues, and related US and international laws.
  • Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing and aseptic processing.
  • *Level will be determined based on skills and experience relevant to the role.*
  • **This position requires at least 35% travel**
    

Keywords: Passage Bio, Lower Merion , Director Quality Assurance (Audit) - Cell/Gene Therapy, Healthcare , Philadelphia, Pennsylvania