Sr Mgr Risk Management Small Molecules Platform

About This Role

This role facilitates risk management activities for Johnson & Johnson Innovative Medicine's Quality & Compliance Small Molecule (SM) Platform. It is critical for implementing and effectively executing risk management across SM sites and the platform.

Responsibilities

• Lead SM platform Community of Practice for Risk Management, driving expertise across all SM sites.
• Oversee end-to-end risk management processes, ensuring comprehensive risk assessments, effective mitigation strategies, and continuous monitoring.
• Collaborate with global functions, across platforms, and with SM sites to ensure effective implementation of risk management.
• Lead risk management governance for SM platform including risk register reviews, risk escalation and remediation.
• Collaborate to understand regulatory trends and ensure incorporation into the risk process.
• Identify and evaluate opportunities for process improvement at SM sites and platform.
• Reinforce compliance and quality within the organization, ensuring effective implementation of compliance strategies.
• Ensure visibility and governance of risk activities and interdependent activities for the platform sites.
• Facilitate governance and visibility of risk management across the SM Platform quality risk metrics.
• Implement and maintain a quality risk management program in compliance with ICH Q9 and IM procedures.

Requirements

• BS degree
• 12+ years of experience with 5+ years in a quality function leading on 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 a deep understanding of Global cGMP requirements
• Experience in the identification and management of risks, including development of risk-based remediation strategies
• Strong influencing and negotiation skills
• Excellent written and oral communication skills
• Strong interpersonal skills
• Subject Matter Expert in risk assessment tools and risk management processes
• Strong computer skills with Quality Systems

Qualifications

• BS degree required.
• At least 12 years of experience with 5+ years of demonstrated leadership in a quality function working on complex 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