Sr Mgr Risk Mgmt SM Platform

Johnson & Johnson•Titusville, NJ

2d•$122,000 - $212,750

About The Position

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 https://www.jnj.com 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.

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 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.

Nice To Haves

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.

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.

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.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits