Johnson & Johnson Innovative Medicine · 5 hours ago
Sr Mgr Risk Management Small Molecules Platform
Athens, GA
Full-time
Onsite
Senior Level, Lead/Staff
12+ years expJohnson & Johnson Innovative Medicine is dedicated to healthcare innovation, striving to prevent, treat, and cure complex diseases. The Senior Manager of Risk Management will facilitate risk management activities for the Small Molecule Platform, overseeing risk assessments and mitigation strategies while ensuring compliance and quality across the platform sites.
Pharmaceuticals
Responsibilities
Lead SM platform Community of Practice for Risk Management, driving risk management and risk assessment expertise across all SM sites
Oversee end-to-end risk management processes, ensuring comprehensive risk assessments, effective mitigation strategies, and continuous monitoring are implemented across the 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
Reinforce the importance of compliance and quality within the organization, ensuring the effective implementation of compliance strategies and our ability to detect and quantify risk appropriately
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
Lead Community of Practice across platform identifying and implementing best practices and implementing process
Lead and facilitate risk management process for platform including oversight forums and integration across all platform governance
Implementing and maintaining a quality risk management program in compliance with ICH Q9 and IM procedures across the SM Platform
Collaborate with key stakeholders to develop integrated risk-based approaches to collect, standardize, analyze as well as maintain risk-assessments and plans at SM sites and platform level
Contribute in business cycles and portfolio management to ensure appropriate visibility of risk mitigation activities in business planning processes
Provide subject matter expertise to sites in risk assessment activities including training and execution
Partner with global risk management to ensure SM platform and sites maintain a risk management program in compliance with Enterprise and IM Q&C requirements and process
Qualification
Required
BS degree required
Requires 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
Must have comprehensive knowledge of GxP, GMP, cGMP and IT compliance regulations and guidelines, with expert knowledge of US and EMEA Regulations
Strong Quality and Compliance background with a deep understanding of Global cGMP requirements and the systems used to deploy them
Experience in the identification and management of risks, including the development of risk-based remediation strategies and reporting risks/status in a concise manner
Strong influencing and negotiation skills
Excellent written and oral communication skills
Strong interpersonal skills, including ability to communicate with individuals and groups at all levels. Experience establishing relationships with other functions within the company
Strong decision making and analysis skills
Demonstrated conflict and change management skills
Subject Matter Expert in risk assessment tools and risk management processes
Strong computer skills with Quality Systems
Sense of Urgency - ability to lead and deliver on multiple projects in a timely manner
Teamwork and Collaboration – ability to lead, manage and participate on teams with shared responsibility for decisions and results
Preferred
Masters or advanced degree in a scientific field (Life Sciences, Pharmacy, Engineering) desirable
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
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
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