Senior Manager Risk Management Small Molecules Platform

About This Role

The Sr. Manager of Risk Management will facilitate and lead risk management activities for the Innovative Medicine Quality & Compliance Small Molecule Platform sites and teams at Johnson & Johnson. This strategic role is crucial for implementing and effectively executing risk management across the platform, ensuring compliance and continuous improvement.

Responsibilities

• Lead Small Molecule (SM) platform Community of Practice for Risk Management, driving risk expertise across all SM sites
• Oversee end-to-end risk management processes including assessments, mitigation strategies, and continuous monitoring across SM platform sites
• Collaborate with global functions and SM sites to ensure effective implementation of risk management and assessment
• Lead risk management governance for the SM platform, including risk register reviews, escalation, and remediation
• Collaborate to understand regulatory trends and incorporate them into the risk process at sites and platform
• Identify and evaluate opportunities for process improvement at SM sites and platform based on compliance and risk monitoring outcomes
• Reinforce compliance and quality, ensuring effective implementation of strategies and appropriate risk detection and quantification
• Ensure visibility and governance of risk activities and interdependent activities (e.g., Quality Plan) for the platform sites
• Facilitate governance and visibility of risk management across the SM Platform quality risk metrics, risk review results, and risk mitigation actions
• Implement and maintain a quality risk management program in compliance with ICH Q9 and IM procedures across the SM Platform

Requirements

• BS degree
• 12+ years of experience with 5+ years in a quality function with demonstrated leadership in complex compliance topics
• Comprehensive knowledge of GxP, GMP, cGMP and IT compliance regulations and guidelines
• Expert knowledge of US and EMEA Regulations
• Strong Quality and Compliance background with deep understanding of Global cGMP requirements
• Experience in identification and management of risks, including development of risk-based remediation strategies and reporting
• Strong influencing and negotiation skills
• Excellent written and oral communication skills
• Strong interpersonal skills and experience establishing relationships with other functions
• Subject Matter Expert in risk assessment tools and risk management processes
• Strong computer skills with Quality Systems

Qualifications

• BS degree required. Masters or advanced degree in a scientific field (Life Sciences, Pharmacy, Engineering) desirable.
• At least 12 years of experience with 5+ years in a quality function working on complex and significant compliance topics.

Nice to Have

• Masters or advanced degree in a scientific field (Life Sciences, Pharmacy, Engineering)
• Experience with Regulatory Authorities
• Industry experience supporting remediation activities
• Knowledge and experience with ISO 31000 Quality Risk Management, ISO 9001 Quality Management Systems, ICH Q9, data analytics and reporting
• Experience in working in a global environment
• Process Excellence experience

Skills

* Required skills