Senior Manager Risk Management SM Platform

About This Role

The Sr. Manager Risk Management facilitates and leads Risk Management activities for Johnson & Johnson Innovative Medicine Quality & Compliance Small Molecule (SM) Platform sites. This role is crucial for implementing and effectively executing Risk Management processes across the sites and 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 across SM platform sites.
• Collaborate with global functions, across platforms, and with SM sites to ensure effective implementation of risk management and assessment.
• Lead risk management governance for SM platform including risk register reviews, risk escalation, and risk remediation.
• Collaborate with global functions, platform team, and site quality organization to understand regulatory trends and ensure incorporation 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.
• Ensure visibility and governance of risk activities and interdependent activities (i.e. 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.
• Implementing and maintaining a quality risk management program in compliance with ICH Q9 and IM procedures across the SM Platform.
• Provide subject matter expertise to sites in risk assessment activities including training and execution.

Requirements

• BS degree
• 12+ years of experience with 5+ years in a leadership quality function
• 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 and reporting risks/status
• 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 plus years’ experience and demonstrated leadership 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, including developing compliance and sustainable solutions to audit/inspection findings, QMS trends, etc.
• 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

Benefits