Sr Mgr Risk Management Small Molecules Platform

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function
Quality

Job Sub Function
Quality Assurance

Job Category
Professional

All Job Posting Locations:
Athens, Georgia, United States of America, Beerse, Antwerp, Belgium, Dublin, Ireland, Geel, Antwerp, Belgium, Gurabo, Puerto Rico, United States of America, Horsham, Pennsylvania, United States of America, Huejotzingo, Puebla, Mexico, Latina, Italy, São José dos Campos, São Paulo, Brazil, Titusville, New Jersey, United States of America

Job Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

The Sr. Mgr. Risk Management facilitates the Risk management activities for the Innovative Medicine Quality & Compliance Small Molecule (SM) Platform sites and teams. This position is critical to the implementation of and effective executive of Risk Management at the sites and across the platform.

Key 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.

Major Duties & Responsibilities

• 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.

Required Minimum Education
BS degree required. Masters or advanced degree in a scientific field (Life Sciences, Pharmacy, Engineering) desirable.

Required Years Of Related Experience

• 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

Required Knowledge, Skills And Abilities

• 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.
• Experience with Regulatory Authorities is a significant asset
• 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.

This position is located in the US or EU and can be based on any Innovative Medicine Supply Chain site.

Travel requirements: approximately 10-20% global travel will be required.

Preferred Related Industry Experience (if Applicable)

• 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.

Required Skills
Preferred Skills:
Business Alignment, Collaborating, Compliance Management, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Mentorship, Organizing, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility