Associate Director, Internal Auditing

Jobtailor; New Jersey; On-site; USD 110,000 - 165,000; Full time

Job summary

Jobtailor is seeking a senior QA/compliance professional to lead continuous GMP compliance, audits, and regulatory readiness for investigational medicinal products. The role spans multiple functions including quality assurance, CSV, manufacturing, and clinical supply.

You will develop metrics, interpret regulations, and guide cross-functional teams to ensure inspections pass and processes improve. A strong track record in audits and risk management is essential.

Qualifications

• Bachelor's degree in Science, IT, or Engineering.
• Minimum 8 years of experience in pharmaceutical/biopharma roles.
• Experience across QA, CSV, manufacturing, R&D, supply chain, facilities, and engineering.
• Strong knowledge of FDA and EU GMP and ICH guidelines.
• Experience leading audits and risk-based assessments.
• Ability to travel between West Point, PA and Rahway, NJ.
• Proficiency with electronic quality systems and metric/KPI reporting.
• Strong communication, presentation, and leadership skills.
• No visa sponsorship.

Responsibilities

• 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 KPIs 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.

Skills

Leadership

Attention to Detail

Project Management

Verbal Communication

Written Communication

Education

Bachelor's degree in Science/IT/Engineering

Advanced degree preferred

Tools

Delta-V

PAS-X

SAP

Electronic Laboratory Notebooks

Veeva

LIMS

Empower

MS PowerPoint

MS Excel

MS Word

Job description

• 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