Lead, QA Strategy

Johnson & Johnson is a global health care company that develops medicines, medical devices and consumer products. We are committed to creating solutions that prevent, treat and cure complex diseases and to improving patient outcomes worldwide.

Quality

Quality Systems

Professional

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

We are searching for the best talent for a Transcend: QA Strategy Lead! This role can be based across several listed locations, with a strong preference for Latina, Italy or Cork, Ireland. It is a critical leadership position where you will be the voice of quality for one of the largest ERP transformations in the pharmaceutical industry. You will own and shape the program‑level QA strategy end‑to‑end, defining the Quality Plan, setting risk tolerance and acceptance criteria, and ensuring every release is inspection‑ready and aligned with program timelines.

Reporting to the QA Director, you will be the single point of accountability for QA strategic decisions across the program.

• 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.
• 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.

• Bachelor’s degree or equivalent required; preferred area of study:
  Supply Chain, Quality or related.

• 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.

• Familiarity with IM Innovative Medicine Quality Management Systems (COMET, Tru Vault, 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.

• Requires proficiency in English (written and verbal) to communicate effectively and professionally.
• May require up to 30% domestic and international travel…