- 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
Requirements
- 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
Core Competencies
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.
Highest-signal resume keywords
- GMP Compliance
- Computer System Validation (CSV)
- Quality Systems Compliance
- Regulatory Compliance
- Leadership Skills
ATS Optimization Keywords
Hard 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
Soft Skills
- Attention to Detail
- Verbal Communication
- Written Communication
- Presentation Skills
- Project Management
Industry Keywords
- Pharmaceutical Industry
- Biopharma
- Biologics
- CGMP
- ICH Guidelines
- Clinical Supply
- Quality Risk Management
- Aseptic Processing Guidelines
- Investigational Medicinal Products
- Continuous Compliance
Tools & Technologies
- MS PowerPoint
- MS Excel
- MS Word
- Delta-V
- PAS-X
- SAP
- Electronic Laboratory Notebooks
- Veeva
- LIMS
- Empower