Senior Quality Manager

Location
Sunnyvale, CA
Salary
Competitive
Posted
August 16 2017
Ref
53499BR
Position Type
Full Time
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 targetsCollaborate with the various functions to ensure the quality management system is comprehensive, incorporates best practices, and is consistent with the strategic planProduct Development responsibilities including design controls, risk management, document control and record management, and supplier managementManufacturing responsibilities including master record, training, process controls, labeling, change management, and CAPAResponsible for monitoring measurement including validations, calibrations, customer feedback and complaints, quality manual, internal auditsWork 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 metricsResponsible for all CCS quality metrics and reporting for monthly and quarterly business reviewsManage a team of 6 quality specialists, across 5 sites globallyEnsure 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 preferred8+ years of professional quality experienceStrong Quality Management Systems experienceStrong management and proven employee development experience. Ability to develop consensus Experience in Chromatography Consumables desiredUnderstanding of the pharmaceutical and biopharmaceutical industry and required compliance regulations for our products and processesExpert working knowledge and experience with ISO 9001Experience in 134845, 21CFR820, and GxP requirements desiredASQ Quality Engineer Certification desirableExpert 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 levelsExperience providing customer support, investigations, and relationship managementProven communication and customer management skillsExperience supporting change management effortsDemonstrates personal awareness and desire for continual learning and personal developmentSelf-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



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