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Manager, Quality Compliance

Company: Thermo Fisher Scientific
Location: Pleasanton
Posted on: November 23, 2021

Job Description:

Job Title: Manager, Quality Compliance - Field Actions and Recalls, GSD Requisition ID: 180091BR When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals. Location/Division Specific InformationAt Genetic Sciences Division (GSD), a division of Thermo Fisher Scientific, we deliver - industry-leading genetic sciences tools and solutions to advance scientific discovery, enable customers in applied markets and improve global health outcomes. Specifically, GSD workflows enable biomarker discovery and analysis, predictive genomics, reproductive health solutions, pathogen detection, disease-specific solutions, forensics, and human identification.As part of the GSD Quality and Regulatory organization, you will have the opportunity for ensuring a compliant global GSD Quality Field Actions and Recall Process. You will be a leader in driving the quality culture mindset -to ensure quality is right the first time, with the customer in mind- at Thermo Fisher Scientific.The position will be a remote based position, ideally based near our Pleasanton, CA or Austin, TX site.How will you make an impact? This position is responsible ensuring a compliant global Genetic Sciences Division (GSD) Field Actions and Recall Process. More specifically the position will be responsible for - the ownership of the divisional field action and recall policy, including standard workflows to support the policy, key trainings for the process and deploy those trainings throughout the organization, identify and monitor KPIs for the process, identify and drive continuous improvement activities. The position will be responsible to identify resource needs to support the process as well as work with key stakeholders throughout the global organization including Product Management, Regional Regulatory, Quality Operations, Commercial, Legal and the Service Organization. If you thrive on working on diverse and concurrent projects, are comfortable working in a dynamic and fast paced environment and are an effective communicator - Thermo Fisher Scientific would like you to help fulfill its mission to enable our customers to make the world healthier, cleaner, and safer. What will you do?

  • Ensuring that field action processes are adequate to ensure the expectations of regulators and key stakeholders are met
  • Provide oversite and coordination to all activities and deliverables within the process while working with the appropriate stakeholders.
  • Responsible for controlling the records generated for the process, not limited to the recall responses and ensuring the recall file is maintained up to date per regulatory requirements
  • Establishing and managing the budget and resources required to ensure the process meets regulatory and quality requirements
    • Manage the issue escalation process as an input into the field action and recall process
    • Ensure issues are aligned to appropriate CAPA and risk documentation
    • Collaborate and communication with necessary stakeholders including Senior Leadership, Commercial, Quality and Regulatory
    • Act as Subject Matter Expert for the field action and recall process during inspections and audits as applicable
    • Maintain current knowledge base of field action and recall regulations, corporate policies, and standards to ensure that the GSD quality assurance regulatory field action and recall process remains in compliance with applicable regulatory and corporate standards/requirements.
    • Support of external inquiries regarding field actions
    • Develop, refine, and maintain training on process
    • Serve as expert in field actions and recalls How will you get here?Education
      • Bachelor's Degree is required (Biological sciences, Engineering or related degree)Experience
        • A minimum of 5+ years of related experience in post market surveillance/corrections and removal/field action in a regulated industry
        • Strong understanding of medical device or in-vitro diagnostic regulations and standards
        • Has effectively lead projects and cross-functional teams Knowledge, Skills, Abilities
          • Strong and effective communicator, written and oral across all levels of the org with a diverse group of individuals
          • Strong knowledge of quality procedures, processes and guidelines and be able interpret and operationalize quality system regulations in the applicable area
          • Excellent organization and time management skills
          • Able to concurrently oversee/contribute to multiple large-scale projects
          • Can effectively and concisely present information across all levels of the organization
          • Strong project management skills At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer. Apply today! 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.

Keywords: Thermo Fisher Scientific, Santa Rosa , Manager, Quality Compliance, Executive , Pleasanton, California

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