Johnson & Johnson Innovative Medicine · 10 hours ago
Sr Mgr Risk Mgmt SM Platform
Horsham, PA
Full-time
Hybrid
Senior Level, Lead/Staff
$122K/yr - $213K/yr
12+ years expJohnson & Johnson Innovative Medicine is a leader in healthcare innovation, dedicated to preventing, treating, and curing complex diseases. The Senior Manager of Risk Management will facilitate risk management activities for the Innovative Medicine Quality & Compliance Small Molecule Platform, overseeing risk assessment processes and ensuring compliance across multiple 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. Masters or advanced degree in a scientific field (Life Sciences, Pharmacy, Engineering) desirable
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
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
Preferred
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
Benefits
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year.
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year.
Holiday pay, including Floating Holidays –13 days per calendar year.
Work, Personal and Family Time - up to 40 hours per calendar year.
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days.
Volunteer Leave – 32 hours per calendar year.
Military Spouse Time-Off – 80 hours per calendar year
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
Company data provided by crunchbase