Senior Manager QC, ATQ

Johnson & Johnson•Raritan, NJ

50d

About The Position

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.

Requirements

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, handling priorities and delivering results with minimal direction.
Proficient with project tools (MS Project, JIRA, Confluence, SharePoint) and MS Office (Excel, PowerPoint).
Flexible, thorough, and accurate, with the ability to perform under changing priorities and timelines
A minimum of ten (10) years of relevant work experience is required, demonstrating dynamic responsibility in quality, project, or laboratory environments.
Professional proficiency in English
Travel percentage will be up to 20%.

Nice To Haves

Process excellence and lean tools
GMP and Quality systems
Pharmaceutical guidelines, including ATMP and Data integrity guidelines

Responsibilities

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.

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
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 period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year