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Job ID :
44433BR
Location :
US - California - Fremont
:
Job Description

Position Summary:

Responsible for assuring company wide compliance with FDA/GMP/QSR and FDA and ISO 9001/13485/CMDR/CE commitments. Failure to identify and recommend corrective actions could result in legal enforcement action, critical delays in schedules and/or departmental operations and may jeopardize overall business activities.

• Ownership of the Corrective and Preventive Action system.
• Management of technical staff directed to closing and audit of CAPAs.
• Communication of CAPA status to executive management.
• Management of OEM customer Supplier Corrective Action Reports.
• Communication to OEM customers of status of SCARs.
• Management of technical staff dedicated to completion of OEM SCARs and response to OEM customers


Key Responsibilities:

  • Lead continuous improvement of Quality Systems, such as (CAPA, Deviation Management, and Change Management), and direct the efforts to develop, implement and maintain compliant and effective Quality Systems.
  • Lead cross-functional teams to complete projects, address quality issues and implement quality system improvements.
  • Identify compliance gaps and lead focused teams to resolve compliance issues.
  • Lead department projects of varying complexity.
  • Support the promotion, socialization, development and implementation of Corrective and Preventative Action system.
  • Assign, manage and review progress and accuracy of work for an individual, or a group of employees.
  • Lead by example to foster a commitment to quality in personnel, and a culture of quality within the organization.
  • Interact and influence peers to ensure successful project completion.
  • Maintain current knowledge of Compliance program and of applicable company standard operating procedures for areas of responsibility.
  • Provide guidance on interpretation and application of specified QA compliance regulations.


Minimum Requirements/Qualifications:

Essential:

  • Position requires a 4-year degree in a technical/science area; an advanced degree is preferred.
  • More then 6 years in a regulated industry with 3 or more years in a management position is also required.
  • Significant experience with quality systems in an IVD/Medical device environment is also required.
  • Incumbent must possess strong interpersonal and communication skills.
  • Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs).
  • Demonstrates in-depth knowledge of QA systems principles, concepts, industry practices, and standards.
  • Demonstrates excellent verbal, written, and interpersonal communication skills.
  • Keen understanding of international quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives.
  • Demonstrated experience as a change agent in driving complex change, understanding the cultural dynamics of the current state of an organization, creating a strategic practical course, balancing the current reality with the need for rapid adoption of the desired future reality which then generates change with a high degree of transformation

Desirable:

  • Direct experience with managing key Quality Management System processes, such as CAPA, Deviation Management, Change Management and Management Review
  • In-depth understanding of current global regulatory expectations, such as 21CFR Parts 210 & 211 and 21CFR part11
  • Excellent organization skills and ability to work on a number of projects to tight timelines.
  • Demonstrated leadership skills associated with the management, leadership and development of staff.
  • Excellent attention to detail, and ability to consistently meet high standards of quality required in QA Compliance.
  • Experience identifying changes, driving improvements and streamlining processes
  • Proficient with the Microsoft Word, Excel, PowerPoint and Outlook.



Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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