Laboratory Compliance Management - R&D Medical Devices

Job Description

Individual Contributor (no direct reports) role that Requires  laboratory managerial experience.  Others need not apply.

This position will be responsible for Laboratory Compliance for all Research and Development laboratories at the Siemens Healthineers Edgewater, Norwood, MA Point of Care site. This position will report directly to Vice President of R&D.

The successful candidate will be an accomplished scientist/quality assurance specialist with extensive knowledge in cGLP who wishes to join a highly talented and motivated R&D team responsible for the product development for the Point of Care portfolio. You will make authoritative decisions and recommendations that have a major impact on lab compliance. This position will require frequent inter-organizational and external contacts.

Develops and supervises departmental operation audits and communicates results to laboratory management. Conducts audits and evaluates and prepares reports recommending improvements in process and workflow for laboratories. Implements protocols, tools and systems for the efficient monitoring, prevention and correction of quality deviations. Assures that responses to audits, both internal and external, are well documented. Authors and revises, as needed, departmental SOPS related to compliance, quality, and laboratory general policies. Supports in technical review of laboratory documents (e. g. SOPs, analytical data, etc.).  Collaborates with management and supervisory personnel from R&D, Environmental Health and Safety, and Quality Assurance to resolve problems affecting laboratory quality. Collaboration includes reacting, investigating and following up for non-conformance issues and working jointly towards resolution. Participates and supports CAPA Review Board meetings, including follow up actions.  Facilitates and conducts training. Accountable for ensuring continual cGMP compliance in the laboratory. Responsible for driving continuous improvement initiatives. Assures proper qualification, maintenance and calibration of lab equipment and on-line test instruments. Creates, measures and tracks compliance metrics. Data review and trend analysis for laboratory QC. Maintain R&D laboratory IT infrastructure. Maintain competency in the current GLP regulations.
Responsible for developing a culture that recognizes laboratory quality assurance and compliance as an essential part of its operations.

The candidate must also have the following skills:

Critical Thinking and Problem Solving

Detail Oriented

Leadership

High Ethical Standards

Required Education, Skills & Experience:

  • MS in Chemistry or equivalent experience is preferred with a minimum of 7-10 years in laboratory management
  • Excellent foundation in science plus laboratory managerial experience
  • Extensive knowledge with cGLP documentation and procedures
  • Ability to effectively communicate downward and upward within the organization as well as externally
  • Ability to lead and motivate a technical team is essential

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Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Mid-level Professional

Job Type: Full-time



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