This role can be based out of any major JnJ location for Medical Devices.
The Senior Manager Quality Systems is a business enabler. They connect with the appropriate functions in the organization, builds partnerships, balances regulatory needs and customer requirements to build a strong, reliable and efficient EMEA Quality Management System for Medical Devices and Medicinal products.
They manage the day-to-day operations of the Quality Systems and the team. Oversees the development and implementation of processes, procedures and ensures they are lean, fit for purpose and efficient across the region and that redundancies are minimized /eliminated.Ensures effective communication to all levels of the organization and that trainings are effectively deployed throughout the business.
- They build and manage a high performing QMS team, oversees delegation of tasks and projects and ensures resources are optimally allocated.
- Provide leadership, technical expertise and coach the team and overall organization.
- Are responsible for ensuring a robust development, implementation, sustainability and continuous improvement of processes such as Training, CAPA, Change Control, Risk Management, Internal Audit, Inspection Readiness, Records management, Quality Manual, SOPs deployment, ICQAs, Metrics, Escalations, Field Actions management, interface with & support to regulatory process etc. in accordance with applicable standards.
- Work with functional partners across the region and globally to ensure reliable QMS effectiveness data is available, obtained from quality databases /systems and files, are well understood and included in management reports and review meetings. Ensures day-to-day decisions are well supported, properly documented and corrective /preventive actions are in place.
- Examine results and metrics from management reviews, third party inspections and internal/ corporate audits and reviews/ approve proposed corrective actions.
- Lead projects aiming to simplify / streamline processes across the organization, reduce redundancies and further improve compliance in a changing environment.
- Lead the ISO certification & maintenance of the EMEA BQ MD QMS.
- Are a strong communicator and ensures adequate communication of quality & compliance needs and status to all affected stakeholders at different levels of the organization.
- Ensure critical issues/ risks are timely escalated to the Leadership Team (LT).
- Represent the EMEA region in review boards and steering committees.
- University/Bachelor’s Degree or Equivalent
- Requires 8-10 years related experience equivalent function
- Strong QMS knowledge on all the listed processes
- Strong communication and presentation skills
- Ability to translate complex information/ data into easy to understand concepts to support reliable decision making at all different levels of the organization (from operational to senior leadership)
- Executive presence
- Excellent written and oral English communication - any other language is a plus
- Proven track record of managing a diverse and virtual team
- Strong collaboration skills and ability to build partnerships
- Strong coaching skills
- Strong analytical and reporting skillsProject Management experience (FPx preferred) and Principles of Process Excellence & Lean are a plus.
Johnson&Johnson Med GmbH (7930)