Associate Director, Internal Auditing

• Develop, implement, and maintain processes and procedures supporting continuous compliance of investigational medicinal products with cGMPs and international regulations
• Lead and support comprehensive internal audits and assessments of GMP facilities and business applications or systems supporting clinical supplies manufacture, testing, storage, and distribution
• Issue audit reports, track resulting actions to satisfactory closure, and maintain appropriate site risk posture
• Develop metrics and key performance indicators to measure trends and improve quality performance
• Escalate unresolved issues and trends to management
• Present audit outcomes to management and governing Quality Councils when applicable
• Provide guidance and interpretation of GMP, regulatory, and compliance standards
• Develop and harmonize compliance procedures and processes aligned with worldwide regulations and industry standards
• Lead and support GMP readiness activities for new manufacturing facilities, laboratories, and support areas
• Support preparation and execution of Health Authority Inspections and company audits
• Promote quality and operational excellence
• Identify and implement improvement opportunities across multiple organizations
• Represent Development Quality on inter-departmental and cross-functional teams
• Support risk identification and remediation for risk assessments

• Required:
  
  Bachelor's Degree in appropriate Science, IT, or Engineering discipline
• Minimum 8 years of experience in the pharmaceutical, biopharma/biologics, or related industry
• Experience in multiple functional areas such as quality assurance, computer system validation, quality control, manufacturing, research and development, supply chain, facilities, and engineering
• Extensive knowledge of FDA and EU GMP regulations and ICH guidelines
• Demonstrated knowledge and direct experience applying System Document Lifecycle requirements in GMP areas
• Experience leading audits
• Ability to travel between West Point, PA and Rahway, NJ
• Strong leadership skills and ability to lead cross-functional teams
• Experience using electronic quality systems to monitor, report, and track quality tasks and KPIs
• Excellent attention to detail
• Proficiency with digital tools and computer applications, including MS PowerPoint, Excel, and Word
• Excellent verbal, written communication, and presentation skills
• Ability to prioritize and manage multiple projects and tasks independently
• Preferred:
  Advanced degree
• Preferred:
  Familiarity with R&D or clinical supply areas and processes
• Preferred:
  Experience with Delta-V, PAS-X, SAP, electronic laboratory notebooks, Veeva, LIMS, or Empower
• Preferred:
  Experience using AI tools and applications
• Preferred:
  Quality Risk Management tools experience
• Preferred:
  Experience leading or supporting US and EU health authority inspections
• Preferred:
  Understanding of lean sigma principles and tools
• Preferred:
  Sterile manufacturing experience and knowledge of US and EU aseptic processing guidelines
• Required skills:
  
  Computer System Validation (CSV), GMP Compliance, Medical Device Regulations, Quality Systems Compliance, Regulatory Compliance
• Valid driving license required
• No visa sponsorship

Demonstrates extensive knowledge of FDA and EU GMP regulations, quality assurance, and compliance standards, with a strong ability to lead audits and cross-functional teams. Proficient in developing metrics and key performance indicators to enhance quality performance and operational excellence.

• GMP Compliance
• Computer System Validation (CSV)
• Quality Systems Compliance
• Regulatory Compliance
• Leadership Skills

• GMP Regulations
• Quality Assurance
• Quality Control
• System Document Lifecycle
• Audit Leadership
• Risk Assessment
• Lean Sigma Principles
• Sterile Manufacturing Knowledge
• Health Authority Inspection Experience
• Digital Tools Proficiency

• Attention to Detail
• Verbal Communication
• Written Communication
• Presentation Skills
• Project Management

• Pharmaceutical Industry
• Biopharma
• Biologics
• CGMP
• ICH Guidelines
• Clinical Supply
• Quality Risk Management
• Aseptic Processing Guidelines
• Investigational Medicinal Products
• Continuous Compliance

• MS Power Point
• MS Excel
• MS Word
• Delta-V
• PAS-X
• SAP
• Electronic Laboratory Notebooks
• Veeva
• LIMS
• Empower