Source Compliance Specialist

Responsibilities

• Establish and maintain a robust compliance program for regulatory, company, and J&J Corporate requirements
• Lead and oversee nonconformity, CAPA, escalation, and internal/external observation activities
• Act as single point of contact for Audit Readiness and Audit Support activities for the Source Quality global team
• Lead and manage internal/external audit readiness, including logistics, front-room/back-room arrangements, SME preparation, and site support
• Partner with site leadership during Notified Body, Health Authority, Ministry of Health, FDA, Regulatory Agency, JJRC, and ERC audits
• Provide timely information and daily communications during audits and inspections
• Report external audit results to responsible management
• Guide preparation of responses to audits, inspections, and regulatory notifications associated with Purchasing Controls
• Ensure timely responses to audit observations, including failure investigations, root cause analysis, corrective/preventive action plans, effectiveness monitoring, and closure
• Represent compliance on sector, enterprise, site, and project teams as appropriate
• Support deployment of J&J Quality System standards at sites
• Collaborate with compliance teams across sites and regions
• Escalate quality issues according to established procedures
• Communicate compliance trends, initiatives, and regulatory changes to management
• Proactively identify and alert management to quality issues
• Support implementation of new regulations and standards
• Maintain current regulatory knowledge through publications, seminars, professional affiliations, and industry meetings
• Establish collaboration with site business partners including Quality Systems, Regulatory Compliance, Quality Operations, Training, and Manufacturing
• Provide or coordinate compliance education and training on QSR, ISO, and related requirements
• Follow and ensure compliance with environmental, safety, and occupational health policies
• Communicate business issues or opportunities to the next management level
• Perform other assigned duties

• A minimum of a bachelor’s degree in engineering, Applied Science or a related technical and quality field is required
• A minimum of 4 years of work experience in a highly regulated Industry is required
• Practical experience with GMP documentation and writing skills in the FDA regulated environment is required
• At least 2 years of experience in external audit readiness and management is preferred
• Source Quality or Procurement experience is preferred
• Strong communication skills in English, written and oral
• Knowledge of applicable regulatory requirements, company policies and procedures, and J&J Corporate requirements
• Knowledge of Purchasing Control Quality Systems Procedures
• Ability to work with GMP, FDA, ISO, QSR, ISO 14001, and OSHA/OSHAS requirements
• Ability to lead audit readiness, audit support, NC, CAPA, escalation, and observation activities

Demonstrates expertise in establishing and maintaining compliance programs, leading audit readiness and support activities, and ensuring adherence to regulatory requirements such as GMP, FDA, ISO, and QSR. Proficient in communication and collaboration with cross-functional teams to address quality issues and implement corrective actions.

• Compliance Program Management
• Audit Readiness and Support
• GMP Documentation and Writing
• Regulatory Knowledge (FDA, ISO, QSR)
• CAPA and Nonconformity Management

• GMP Documentation
• Audit Management
• Root Cause Analysis
• Corrective Action Plans
• Quality Systems Procedures
• Regulatory Compliance
• Quality Control
• Environmental Health and Safety Compliance
• Training Coordination
• Escalation Procedures

• Strong Communication Skills
• Collaboration
• Proactive Problem Solving
• Leadership
• Interpersonal Skills

• Regulatory Requirements
• Quality Assurance
• ISO 14001
• FDA Regulations
• J&J Corporate Standards
• Purchasing Controls
• Health Authority Audits
• Notified Body Audits
• Occupational Health Policies
• Quality Management Systems