Sr. Manager - Reagent Control Project
Business Unit: Healthineers (HC)
Requisition Number: 224696
Primary Location: United States-Massachusetts-East Walpole
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 5%
With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.
For more information, please visit: http://www.usa.siemens.com/healthcare
- Direct supervision and management of Control Systems Improvement team members.
- Develop strategies, and plans to implement actions that will ensure success of on-time completion of Control Systems Improvement schedules and deliverables.
- Facilitate cross functional communication and collaboration across the organization in order to identify opportunities and eliminate obstacles.
- Tactical and strategically plan ahead and identify challenges before they impact Control System Improvement deliverables.
- Develop new processes as needed.
- Actively track issues/projects/timelines.
- Ensure alignment and integration with overall Control System Improvement strategy and deliverables.
- Communicate status of issues/projects on a regular basis to all levels of the organization.
- Understanding of the assay architecture, design of immunoassays. Manufacturing experience a plus.
- Experience in Design Control; including, Design Change, Process Change, Verification and Validation and Risk Management.
- Good understanding of FDA and ISO regulations.
- Demonstrated ability to analyze problems in a structured and systematic manner with the proven ability to interpret data and to troubleshoot and resolve technical issues.
- Excellent quantitative skills and knowledge of statistics enabling the ability to work cross-functionally with statisticians.
- Ability to multi-task and to support multiple project teams in cross functional settings.
- Excellent organizational, oral and written communication skills.
- Ability to write clear and concise plans and reports and other quality documents.
- A natural ability to manage and develop a diverse team with varying skill sets.
- Minimum of a Bachelor’s degree in Chemistry, Biology or Biological Science.
- 8+ years of successful experience in a directly related field with a demonstrated track record of success.
- Minimum of five years previous management experience.
- Experience working in a regulated industry (for example FDA)
- Previous IVDD experience in a technical role.
- Master’s in related field preferred.