Senior Manager, Risk Management, SM Platform
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Titusville • New Jersey • Pennsylvania • United States
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Salary
💰 $122,000 - $212,750 per year
Job Level
About the role
- 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.
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+ 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.
Benefits
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Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
risk managementquality risk management programrisk assessmentrisk-based remediation strategiesGxPGMPcGMPIT compliance regulationsUS RegulationsEMEA Regulations
Soft Skills
leadershipinfluencing skillsnegotiation skillswritten communicationoral communicationinterpersonal skillsdecision makinganalysis skillsconflict managementchange management