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Lead, QA StrategyJ&J Family of Companies • United States
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Lead, QA Strategy

J&J Family of Companies
  • US
    United States
  • US
    United States
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About

Transcend: QA Strategy Lead
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. 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 Systems Job Category: Professional All Job Posting Locations: Beerse, Antwerp, Belgium, Latina, Italy, Little Island, Cork, Ireland, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America, Zug, Switzerland This is not a checkbox QA role — it's a critical leadership position where you will be the voice of quality for one of the largest ERP transformations in the pharmaceutical industry. If you thrive on building quality strategy from the ground up, challenging the status quo to protect patients, and operating with the confidence and independence to make tough calls — this is your opportunity. As the QA Strategy Lead (PG 31) within the Innovative Medicine (IM) Transcend Team, you will own and shape the program-level QA strategy end-to-end. You will define the Quality Plan, set risk tolerance and acceptance criteria, and ensure every release is inspection-ready and aligned with program timelines. Reporting to the QA Director (PG 40), you will be the single point of accountability for QA strategic decisions across the program — from Quality Risk Management through to business readiness and system acceptance. This role is uniquely broad. You will not just lead strategy — you will drive risk management, business readiness, and system acceptance activities directly, building and delivering the full QA framework with your own hands. You will act as an independent quality voice, constructively challenging project teams to ensure compliance is never compromised for speed. You will operate at the intersection of quality, technology, and business transformation — and you will need to be equally comfortable communicating risk posture to senior leadership. We are looking for someone with a genuine QA mindset — someone who sees quality not as a gate but as a competitive advantage. Someone who can earn trust across business, IT, and compliance partners while never losing sight of one thing: protecting the program and, ultimately, the patient. Key Responsibilities
Own and maintain the Transcend Quality Plan and program‑level Quality Risk Management (QRM) framework, defining risk tolerance and compliance acceptance criteria aligned with program milestones. Provide independent QA oversight and challenge decisions where compliance, data integrity, or patient safety may be at risk. Own the Quality TIME Risk Register, driving identification, assessment, mitigation, and reporting of program quality risks. Lead QRM and QRA execution, produce risk metrics, and drive continuous improvement through lessons learned and preventive actions aligned with enterprise risk frameworks. Ensure end‑to‑end business readiness for each deployment wave by driving the Quality Plan, Business Implementation Plan, and GxP documentation strategy. Review and sign off on training, user access management (UAM), and cutover strategies, and act as the primary GxP advisor to business stakeholders. Own the program's audit trail, data integrity, and system acceptance strategy. Review and sign off on SDLC deliverables (Compliance Analysis, Compliance Plan, Testing Strategy), assess defect severity during UAT and Hypercare, and oversee technical QA topics as needed. Qualifications:
Education: Bachelor's degree or equivalent required; preferred Area of Study: Supply Chain, Quality or related. Experience and Skills:
Required: Minimum 10 years of relevant work experience in Quality Assurance, Quality Management, or Compliance roles within a regulated environment Strong knowledge of regulatory requirements: GMP, GxP, 21 CFR Part 11, EU Annex 11, and data integrity expectations Strong experience in risk management methodologies (QRM, QRA, FMEA, or equivalent) Proven experience with change control, CAPA, deviation management, and audit responses. Hands-on experience with GxP compliance in computerized system validation (CSV) or IT-enabled business transformation contexts Demonstrated ability to operate independently, challenge project teams constructively, and make quality-based decisions with confidence — even under delivery pressure Excellent interpersonal, relationship-building, and influencing skills, with the ability to engage at execution level with project teams and at strategic level with senior leadership Ability to manage and prioritize a broad scope of activities across strategy, risk, readiness, and acceptance simultaneously Preferred:
Familiarity with IM Innovative Medicine Quality Management Systems (COMET, TruVault, Summit). Experience with SAP S/4 HANA or large-scale ERP transformation programs Experience leading or facilitating Quality System Management Reviews (QSMR) Track record of coaching and mentoring business stakeholders on quality and compliance expectations Experience with business readiness activities including training strategy, UAM, and cutover planning for regulated systems Other:
Requires proficiency in English (written and verbal) to communicate effectively and professionally May require up to 30% domestic and international travel depending on work location and business needs Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week
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: Analytical Reasoning, Analytics Dashboards, Compliance Management, Data Gathering and Analysis, Data Quality, Incident Management, Organizing, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Risk Management, Standard Operating Procedure (SOP), System Integration, Systems Analysis, Tactical Planning, Technical Credibility
  • United States

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  • English
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