Senior Manager, Risk Management – Small Molecules Platform
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Athens • New Jersey • Pennsylvania • United States
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Job Level
About the role
- Lead SM platform Community of Practice for Risk Management
- Oversee end-to-end risk management processes
- Collaborate with global functions, across platforms, and with SM sites
- Lead risk management governance for SM platform
- Identify and evaluate opportunities for process improvement at SM sites and platform
- Reinforce the importance of compliance and quality within the organization
- Ensure visibility and governance of risk activities and interdependent activities
- Lead Community of Practice across platform
- Implement and maintain a quality risk management program
- Contribute in business cycles and portfolio management
- Provide subject matter expertise to sites in risk assessment
Requirements
- 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
- Experience in the identification and management of risks
- Strong influencing and negotiation skills
- Excellent written and oral communication skills
- Strong interpersonal skills
- Experience establishing relationships with other functions within the company
- Experience with Regulatory Authorities is a significant asset
- Strong decision making and analysis skills
- Subject Matter Expert in risk assessment tools and risk management processes
- Strong computer skills
Benefits
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Applicant Tracking System Keywords
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Hard Skills & Tools
risk managementquality risk managementrisk assessmentGxPGMPcGMPIT compliancecompliance regulationsportfolio managementprocess improvement
Soft Skills
leadershipinfluencingnegotiationcommunicationinterpersonal skillsdecision makinganalysiscollaborationsubject matter expertiserelationship building