Johnson & Johnson Careers
Director, Business Quality
Requisition ID: 9964180426
Janssen Pharmaceuticals, Inc. a member of the J&J Family of Companies, is recruiting for a Director, Business Quality to be located in Raritan, NJ, Titusville, NJ or Horsham, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it
The Director, Business Quality will serve as a leader of quality and compliance and lead Business Quality for the respective U.S. Janssen commercial businesses (i.e. Cardiovascular & Metabolism, and Established Products).
In this role, you will be responsible for developing and deploying the Quality strategic plan and assuring the integration/alignment into the commercial quality strategy.
Responsibilities include but are not limited to:
- Interface with and represent commercial presidents in areas of quality decisions, such as escalations, field actions and/or other significant quality issues.
- Ensure high quality products and services are available in the US market every day.
- Represent Quality & Compliance to the respective U.S. commercial business Boards and ensures linkage of the business strategies with Quality & Compliance.
- Lead development and execution of the Business Quality (BQ) strategy across the U.S. Local Operating Companies (LOCs).
- Provide leadership and ensure the operational success of quality functions within the commercial organizations, with an emphasis on prevention, continuous improvement, and customer satisfaction.
- Ability to review patient complaints to identify insights to develop patient centric solutions.
- Establish and sustain business quality standards and processes, and ensures integration with other regional business quality and supply chain organizations in Pharmaceutical business.
- Employ the insights obtained from cross-company lessons-learned to create a commercial LOC vision for improved compliance that balances compliance risk with business objectives.
- Work with business partners to ensure alignment of business quality initiatives with strategic business direction.
- Build and implement processes and strategic direction based on R&D, supply chain, and commercial quality management system synergies.
- Ensure that the quality systems supporting the commercial businesses are in a constant state of readiness for planned and ad hoc regulatory audits or inspections conducted by regulatory bodies, competent authorities, or other agencies.
- Provide balanced leadership and management of quality and compliance risks with business needs.
- A minimum of a Bachelor’s degree or equivalent is required.
- A graduate degree focused on Business/Technical/Life Sciences is preferred.
- A minimum of 10 years of management experience in a regulated medical industry (Pharmaceuticals, Medical Devices, Diagnostics and/or OTC) is required.
- Working knowledge of the business environment inside a quality organization, across all various roles (e.g., quality operations, QC, Quality Systems, pre-production quality assurance, validation, market quality,) is required.
- Demonstrated knowledge of applicable regulations within the US (FDA) and the implications of marketing, print, digital is required.
- Experience managing and developing direct reports preferred.
- Demonstrated experience leading professionals in a matrixed environment is required.
- Must have strong presentation skills and the ability to communicate effectively to senior leadership.
- In-depth experience in handling regulatory inspections and inspectional requirements is required.
- Direct working knowledge of the business environment outside of the quality organization (e.g., sales and marketing, manufacturing, product/ process development, customer service, etc.) is preferred.
- Demonstrated strategic thinking capabilities, ability to support development of a vision for the future is a must.
- This position may require up to 10% local travel as business demands.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Raritan
Janssen Pharmaceuticals, Inc (6062)