Senior Manager, Product Quality Management – Product Risk Management

Janssen Supply Group, part of the Johnson & Johnson family of companies, is currently hiring for a Senior Manager, Product Quality Management – Product Risk Management position. This position can be based in Titusville, NJ, Horsham, PA, Beerse, BE or an approved Janssen site in the United States or Europe. Additionally, remote work options may be considered on a case-by-case basis and if approved by the Company.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Group, LLC is part of the Janssen Pharmaceutical Companies.

The Senior Manager, Product Risk Management position provides Quality Assurance & Quality Engineering leadership and oversight to manage and optimize the robustness and consistency for Product Quality Management (PQM) owned Risk Management processes to drive operational and quality excellence across Janssen.

Responsibilities:

• Compliance with the Good Manufacturing Practice (GMP), EHS and SOX requirements and guidelines.
• Provide strategic direction and act as a SME on the implementation of efficient Product Risk Management processes ensuring compliance and consistency with ICH Q8, ICH Q9 and ISO 14971 risk management principles. Serve as Janssen global representative on an Enterprise Level within Johnson and Johnson and relevant external groups.
• Ensure product and process risk management procedures are integrated and understood by key business partners across Janssen organizational sites and functions.
• Oversee the deployment of Product Risk Management processes within Janssen to provide training programs and act as a Qualified Trainer for the deployment of these and any other applicable training programs.
• Provide strategic direction to seamlessly embed Risk Management processes such as Product Risk Management, Criticality Analysis through the entire product life cycle into the Janssen GMP processes (e.g. process validation, technical transfers, quality investigations, reportability, equipment purchases).
• Collaborates to identify, quantify and drive improvement opportunities within PQM using project management and continuous improvement tools to manage and track activities. Builds organizational capability in deployment of improvement methodologies.
• Lead and participate in PQM, Janssen and J&J Enterprise operational improvement projects
• Collaborates to identify, lead, and participate in improvement opportunities within PQM by analyzing data and reports and managing and tracking project activities.
• Remains current in knowledge, skills, and industry trends. Contributes to the strategy setting of the PQM Strategy and Excellence team. Makes a positive contribution by making suggestions for improvement.
• Trains on new regulations, guidelines, procedures, and processes.
• Participates in J&J and Pharma sector initiatives in support of PQM and ownership of other related duties as assigned by management.
• Uses in-depth knowledge of analysis and problem-solving techniques to study reports, identify underlying issues or trends, and assess broader implications of the findings, based upon the interpretation of quantifiable data, to recommend appropriate solutions and seek strategic insights.
• Demonstrates ability to effectively integrate with process stakeholders (both internal and external) to evaluate and execute against innovation opportunities across a broad sphere of responsibilities.
• Leverages understanding of KPI usage to lead the development of achievable improvement goals to close identified gaps.
• Demonstrates ability to apply continuous improvement tools (i.e. Six Sigma, Lean, etc.) and approaches to large/complex projects.
• Demonstrates ability to coordinate and guide others in implementing continuous improvement tools and approaches.
• Drives resource and activity management across senior stakeholders and sponsors to obtain cross-functional and multi-site buy-in and support for project activities, champions the usage and benefits of FPX and other project management approaches and mentors others on their effective application.
• Influences through others to make the case for change relevant and build support for proposed solutions.

Leadership & Behavioral Competencies:

• Identifies new ways of working and creates opportunities for others to be proactive, take calculated risks, learn from mistakes, and make informed decisions.
• Flexible, adaptable, engages, and empowers others to be resilient and agile in changing circumstances.
• Builds trusts with others and seeks to discuss difficult issues or concerns openly and respectfully.
• Develops strong collaborative relationships with others across boundaries.

Required:

• Minimum of a Bachelor’s Degree.
• Minimum of 8 years of experience in a Medical Device, Pharmaceutical, Biotech or related highly regulated industry.
• Minimum of 2 years of experience in New Product Development and/or Combination Products.
• Knowledge of both US and International Risk Management requirements (specifically ICH Q8, ICH Q9 and ISO 14971).
• Experience in leading quality initiatives, managing cross-functional projects, influencing senior management and driving organizational change.
• This position may require up to 10% travel both internationally and domestically.

Preferred:

• Experience in Product Risk Management.
• Cross functional experience in Quality, Supply Chain, and R&D.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.