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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently hiring for a Senior Manager, Quality Strategy! This position will be located in Raritan, NJ

Department Overview

The Raritan IMSC Quality department provides strategic oversight for Quality Assurance, Quality Systems, and Quality Control in support of Janssen Advanced Therapy Supply Chain (ATSC) local operations. The Advanced Therapies platform enables manufacturing and testing for CARVYKTI and Lentiviral Vector products at the Raritan facility, with a focus on maintaining robust compliance, operational excellence, inspection readiness, and reliable patient supply.

Role objective

The Senior Manager, Quality Strategy is accountable for shaping, advancing, and executing the integrated Quality strategy for Raritan across Quality Assurance (QA), Quality Systems (QS), and Quality Control (QC). This role provides strategic leadership, governance, and execution discipline for priority Quality initiatives, ensuring alignment to site, platform, and enterprise objectives. The role establishes scalable business and quality processes, monitors progress against strategic commitments, enables risk-based decision-making, and drives measurable outcomes that strengthen compliance, operational performance, and continuous improvement across the Advanced Therapies network.

Major Responsibilities

• Lead the development, governance, and execution of the Raritan Quality strategic portfolio across QA, QC, and QS, ensuring initiatives advance site and platform priorities, improve productivity, strengthen compliance, reduce turnaround time, optimize cost, and enhance end-to-end Quality processes. Provide transparent status, risks, decisions, and performance insights to stakeholders and Quality Leadership to support prioritization, timely escalation, and course correction.
• Serve as a strategic partner to local Quality leaders, above-site Quality, JJT, JJRC, and cross-functional stakeholders to enable deployment of Quality improvement initiatives, digital capabilities, and quality system implementations. Represent the Raritan Quality Platform in the planning, alignment, and execution of corporate initiatives and maintain the Raritan Quality systems roadmap to ensure fit-for-purpose, scalable, and compliant solutions.

• Champion cost competitiveness and continuous improvement across the Advanced Therapies Quality network by identifying, sequencing, and enabling delivery of high-impact improvement opportunities in partnership with Site Quality Heads, laboratory leaders, and network stakeholders. Embed strong project management discipline, accountability, and benefits realization across the Quality project portfolio.

• Engage with the Advanced Therapies Quality platform to shape and advance network strategy, objectives, process improvements, and capital project priorities, ensuring local execution is aligned with broader platform direction and long-range business needs.

• Drive and coordinate Quality input for the long-range financial planning (LRFP) process, identifying QA, QC, and QS capability needs in alignment with future network demand. Support disciplined budget management across CAPEX and OPEX to ensure resources are aligned to strategic priorities and operational commitments.

• Enable proactive regulatory and external engagement by monitoring relevant Cell and Gene Therapy quality forums, emerging expectations, regulatory trends, and industry standards. Facilitate assessment of applicable quality and regulatory guidance to support inspection readiness, compliance strategy.

• Develop and execute strategic communication plans that build alignment, engagement, and transparency across the department. Create leadership-ready content, facilitate staff meetings, open forums, town halls, and communications campaigns, and measure communication effectiveness to ensure messages are clear, relevant, and aligned to Quality priorities.

• Coordinate Leadership Team and department operating rhythms by developing agendas, capturing decisions, documenting action items, and driving follow-up to ensure accountability, execution, and sustained momentum on key priorities.

• Partner with HR and department leadership to anticipate workforce, engagement, talent, and organizational planning needs, including communications and coordination for compensation planning, talent management, and year-end performance processes.

• Perform other duties as assigned, consistent with business needs and the evolving priorities of the Quality organization.

Key Competencies/Skills/Requirements

Business Knowledge:

• Broad and deep understanding of Quality Assurance, Quality Control, and Quality Systems in a regulated manufacturing environment is required

• Strong understanding of Quality organization operating models, governance processes, and cross-functional interfaces across site and network roles is required

• Experience in Biologics and/or Cell Therapy is preferred

• Demonstrated leadership as a change agent with the ability to influence transformation, build alignment, and deliver sustained performance improvement

• Proven track record leading business improvement initiatives from strategy through execution and measurable outcomes

• Proven ability to operate effectively in a global matrix environment and influence without direct authority

• Strong business acumen, including experience with budget, capacity, headcount, CAPEX, and OPEX planning

• Ability to translate strategy into actionable plans, establish clear governance, and drive execution to achieve committed results

• Experience in Process Excellence, Design Excellence, Lean, or Six Sigma is highly preferred

• Strong analytical capability, including the ability to evaluate complex issues, apply risk-based thinking, and align policies and processes to business and compliance goals

• Strong organizational, stakeholder management, conflict resolution, and decision-making skills

• Ability to manage multiple priorities, maintain confidentiality, and operate with poise, judgment, and professionalism in a complex, high-profile, and rapidly changing environment

• Ability to resolve and manage operational, quality, and compliance challenges with urgency and sound judgment

• Fluent verbal and written English communication skills; additional language skills are advantageous

• Experience implementing and overseeing GMP operations in a commercial manufacturing facility is required

• Knowledge of FDA and EU cGMP regulations and guidance is required

Communications

• Strong executive presence, negotiation capability, and interpersonal skills, with the ability to communicate effectively across all levels of the organization

• Demonstrated ability to develop strategic and operational communications that translate complex priorities into clear, actionable messages for diverse audiences

• High emotional intelligence with the ability to navigate complex relationships, build trust, and influence outcomes across functions and levels

• Strong judgment and critical thinking, including the ability to ask thoughtful questions, anticipate executive-level concerns, and frame decisions effectively

• Understands when to escalate issues and does so with clarity, professionalism, and appropriate urgency

• Ability to establish clear direction, align stakeholders, motivate teams, and inspire action toward shared objectives

• Experience partnering with senior leaders and stakeholders is required

• Strong written, verbal, and presentation communication skills are required

Continuous Learning

• Demonstrates self-awareness, openness to feedback, and commitment to continuous leadership growth
• Actively owns development planning, career growth, and capability building aligned to current and future business needs

• Benchmarks internally and externally to identify, adapt, and share best practices that strengthen Quality performance

Experience and Skills

Education:

A minimum of a Bachelor’s degree in engineering, science, business, or an equivalent discipline is strongly preferred.

Experience: A minimum of 8 years of experience in Quality Assurance, Quality Systems, Quality Control, Operations, or manufacturing-related functions in a regulated environment is required.

Skills/Abilities:

• Proficiency in Microsoft Word, Excel, PowerPoint, OneNote, and other computer-based applications is required for routine business operations, reporting, and communication

• Working knowledge of quality system applications such as TComet and truVault is highly preferred

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation,  external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$122,000.00 - $212,750.00

Additional Description for Pay Transparency:

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)).

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