Senior Manager Quality Strategy

Job description

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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 thoug