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Job ID :
53499BR
Location :
US - California - Sunnyvale
:
Job Description

Position Summary

Our Chromatography Consumables and Specialty Products Business Group (CCS) is looking for a key member to lead the global Quality function. The Senior Quality Manager, is a new leadership position responsible for developing and implementing our CCS QMS (Quality Management System) and structure to cover our business, create scale, and most importantly, better serve our customers. This position reports directly to the Vice President and General Manager of CCS and will manage quality personnel to achieve Quality objectives and assure compliance with industry standards.

Key Duties and Responsibilities

  • Determine, organize and apply necessary resources to meet identified Quality Requirements and ensure Corporate, Regulatory, Quality requirements are met
  • Ensure that customer expectations are met or exceeded
  • Support and provide expertise to the Quality Management System (QMS) and Quality department to successfully meet or exceed goals and targets
  • Collaborate with the various functions to ensure the quality management system is comprehensive, incorporates best practices, and is consistent with the strategic plan
  • Product Development responsibilities including design controls, risk management, document control and record management, and supplier management
  • Manufacturing responsibilities including master record, training, process controls, labeling, change management, and CAPA
  • Responsible for monitoring measurement including validations, calibrations, customer feedback and complaints, quality manual, internal audits
  • Work with Vice President of Quality for the Chromatography and Mass Spectrometry Division (CMD) and act as a liaison between CMD and CCS business unit to ensure we are meeting division quality standards and metrics
  • Responsible for all CCS quality metrics and reporting for monthly and quarterly business reviews
  • Manage a team of 6 quality specialists, across 5 sites globally
  • Ensure continuous improvement through the Practical Process Improvement (PPI) Program
  • Instill and maintain a quality culture

Minimum Requirements/Qualifications:
  • Bachelors of Science Degree Required - chemical engineering preferred
  • 8+ years of professional quality experience
  • Strong Quality Management Systems experience
  • Strong management and proven employee development experience.
  • Ability to develop consensus
  • Experience in Chromatography Consumables desired
  • Understanding of the pharmaceutical and biopharmaceutical industry and required compliance regulations for our products and processes
  • Expert working knowledge and experience with ISO 9001
  • Experience in 134845, 21CFR820, and GxP requirements desired
  • ASQ Quality Engineer Certification desirable
  • Expert knowledge and experience implementing the following:
    • Advance Product Quality Planning (APQP)
    • Design and Process FMEA’s (Failure Mode Effects Analysis)
    • Global CAPA (Corrective and Preventive Actions) process
  • Ability to contribute as a valued team member and colleague with leaders at all levels
  • Experience providing customer support, investigations, and relationship management
  • Proven communication and customer management skills
  • Experience supporting change management efforts
  • Demonstrates personal awareness and desire for continual learning and personal development
  • Self-motivated with the ability to work independently and to deal with ambiguity.
  • Must possess the presentation skills and professionalism to project a professional image, both internally and externally
This position has been approved to provide relocation assistance



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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