Senior Manager QC, ATQ

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld 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 Med Tech, 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.

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Quality

Quality Control

Professional

Raritan, New Jersey, United States of America

Johnson and Johnson Innovative Medicines, is recruiting for Advanced Therapies Quality QC Senior Manager. At Johnson & Johnson, we are working to create a world without disease. Redefining lives by finding new and better ways to prevent, intercept, treat and cure disease encourages us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.

This role will have a direct and important impact on patients awaiting our Advanced Therapies. Enabling the timely release of safe and effective treatments makes this a highly rewarding and exciting position. We conduct testing in both internal and external quality control laboratories, using a variety of techniques and analytical platforms. The environment is constantly evolving, and major projects are required to maintain and advance our capabilities.

You will play a central role in handling diverse analytical projects that enable compliant, efficient, and reliable product release and QC testing. You will lead change-management initiatives and investigations that accelerate the development of manufacturing and testing processes. Working with teams around the world, you will drive Analytical strategies for Advanced Therapies and handle projects from conceptualisation and prioritization through execution and implementation.

These analytical projects span Finance, CMC, Quality, and Regulatory functions and must be integrated into broader project portfolios and product strategies. You will maintain project overviews and report periodically to senior management and other partners. Sophisticated skills in project management and project visualization are essential for success in this role.

• Lead and coordinate global Analytical projects to ensure compliant, efficient, and reliable product release for Advanced Therapies. Projects will, among other areas, address competitiveness, new technologies, and automation.
• Lead end-to-end project delivery: define scope, develop project plans, lead schedules, and track achievements
• Lead project financials, including budgeting, forecasting, and profitability tracking.
• Coordinate and mentor multidisciplinary teams, ensuring clear roles, responsibilities, and accountability.
• Serve as primary contact for project status, risks, and decision-making; build strong client relationships.
• Identify, assess, and mitigate project risks and issues; drive timely resolution and escalation when needed.
• Use and promote appropriate delivery methodologies (Agile, Waterfall, hybrid) based on client needs.
• Maintain project documentation, status reports, and executive-level presentations.
• Solid analytical and problem-solving skills; comfortable with data-driven decision making
• Integrate projects across Finance, CMC, Quality, and Regulatory functions to ensure alignment with product strategies and program portfolios.
• Support Change management processes and work with regulatory affairs to understand and handle impact of Changes to the supply chain.
• Resolve technical or quality issues together with diverse project teams.
• Apply Quality Systems:
  Event and CAPA Management System, Document Management System, Learning Management System, Change Control System and new technologies.

• Minimum qualification:
  
  Bachelor's degree or equivalent experience.

• Advanced knowledge of Analytical project management, financial processes, change management, and regulatory requirements.
• Confirmed experience leading multidisciplinary, often geographically distributed, teams.
• Sophisticated skills in project visualization and delivering concise, impactful report-outs to Senior Management.
• Exceptional oral and written communication skills; skilled at concise executive reporting and presentations.
• Strong understanding of corporate governance mechanisms and decision-making processes.
• Familiarity with cell therapy, gene therapy, and related analytical techniques.
• Demonstrated affinity for digitalization, automation, and data science; committed to advancing testing automation.
• Solid understanding of management review tools, key performance indicators, and dashboard design to drive performance visibility.
• Excellent social skills, able to influence and engage collaborators across functions and levels.
• Self-motivated and able to work independently,…