Director, Global Quality Systems Production

Our plans for tomorrow are as bold as yours. Schering-Plough has new drugs on the horizon, new partnerships and a renewed dedication to leadership, values and hard work - the same qualities that made us an industry leader for decades. Each day, we grow our relationships and establish the trust of doctors and patients alike, while providing them with a steady flow of the most innovative and effective science-based medicines and services.



As we strive to achieve these goals, our commitment to building a diverse, global, highly skilled workforce has become even stronger, with performance driven incentives, leading edge training and development, and excellent opportunities for professional advancement. We are building a new and special kind of healthcare company. The change, the excitement, the opportunity are infectious.




Director, Global Quality Systems Production

Requisition Number: 16301BR



Responsible for providing strategic direction and technical leadership during the creation, deployment, and implementation of Global Quality Systems which is the foundation for sustainable GMP compliance for manufacturing, quality, and testing operations at all Schering - Plough Global Supply Chain manufacturing sites and SPRI. Provide a formal governance structure to the Schering - Plough hierarchy of GMP Quality Systems which includes Corporate Quality Policies (CQP), Worldwide Quality Standards (WQS/TSIM), Worldwide Guidance Documents (WGD), and Worldwide Quality Procedures (WQP).
Provide production compliance knowledge and expertise to ensure Standards and Guidance Documents are created, revised, and maintained to support sustainable compliance. During the deployment and implementation phases, drive consistency in compliance programs between sites and lead initiatives for global or individual site solutions relating to significant capital / headcount needs identified to support these new systems. Direct a staff of Global Quality System Managers providing compliance oversight on highly technical and regulatory topics, resolving standard escalation issues, as well as facilitating systems improvements at / across sites.

Qualifications
15+ years working experience in the Pharmaceutical industry with a minimum of 8 years in a management role
Significant technical expertise in Production Operations
Expert in Pharmaceutical Regulatory requirements for cGMP comprehension and appropriate interpretation / application for Schering - Plough (FDA & International regulations)
Management of Quality Systems Managers as direct reports
Ability to effectively interface / communicate with Senior Corporate Management, Senior Technical Operations / Quality Management, compliance consultants, and Regulatory Authorities (e.g. FDA, EMEA, etc.)
Strong project management and team building skills
Excellent analytical and organizational skills
Strong interpersonal skills
Strong written and oral communications
Strong negotiation skills and conflict resolution
Strong facilitative leadership role
Ability to influence and drive change in compliance culture worldwide
Willing to travel up to 20% worldwide



As part of the Schering-Plough team, you?ll benefit from strong leadership, a new vision and an empowering corporate culture while enjoying competitive compensation and a progressive benefits package.