Johnson & Johnson Innovative Medicine is looking to solve the problem of ensuring comprehensive Quality Operations in support of their Raritan CAR-T manufacturing site, maintaining full compliance with cGMP, J&J, and JSC requirements, and driving continuous improvement in the production of advanced therapies.
Requirements
- Experience with implementing and coordinating GMP operations in a commercial manufacturing facility.
- Experience leading process optimization initiatives, data-driven decision-making, and the application of quality improvement methodologies.
- Monitor industry trends and emerging best practices to innovate and enhance quality processes within the organization.
- Knowledgeable of Quality Risk Management concepts.
- Experience in regulated environment (FDA, EMA) and other worldwide regulatory agencies and regulatory inspections.
- Significant experience with Advanced Therapies is preferred.
- Serves as SME for QA operations to support all regulatory inspections.
Responsibilities
- Functions and activities include Quality oversight of QA Incoming, QA Shop Floor, Batch Record Review, Drug Product Release, Cryopreservation, Lenti, and QCBB production facilities.
- Develops and implements long-term strategies, and execution of Quality programs.
- Develops, implements and drives a comprehensive Quality Operations strategy, aligned with site goals.
- Leads the establishment and execution of quality objectives and key performance indicators (KPIs) that drive continuous improvement and operational excellence.
- Proactively identifies recurring trends and implements a Right First Time program in collaboration with manufacturing and QC operations to reduce deviations and improve efficiency.
- Ensure effective risk management practices are in place, including identification, assessment, and mitigation of quality-related risks.
- Leads launches of new products and technologies. Participates in product stage gate reviews representing Raritan site Quality Assurance.
Other
- Demonstrated experience building and leading exceptional Quality Assurance teams.
- A minimum of 10 years relevant work experience, with 5 of those years managing a team of senior leaders and professionals within Quality Assurance.
- Provides leadership and direction to the Quality and Site Management Teams to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model.
- Develops and champions an interpersonal culture that promotes behaviors that lead to outstanding business performance and organizational excellence.
- Responsible for appropriately staffing and developing the Quality Operations organization to meet budget and succession plans.
