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Sr Manager, Quality

Job Id R-01281204 Job Type フルタイム Category 品質・薬事 Remote ハイブリッド
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JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards、 Office、 Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Join Thermo Fisher Scientific, to discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science and with the largest investment in R&D in the industry, you will be empowered to realize your full potential as part of a fast-growing, global organization that values your passion and outstanding contributions. We are committed to our 100,000+ colleagues and to make a difference in our world while building an exciting career with us!


Location/Division Specific Information

This role is part of the Laboratory Chemicals Division and will be connected to one of the locations in the network (Geel, Belgium or Tewksbury, Massachusetts)


Make an Impact


We are looking for a dedicated and experienced Senior Quality Manager to lead the Quality function of the Fine Chemical Product business and manufacturing network. This person will be responsible for the activities of Quality across the network, including Quality Assurance and Quality Control. The senior leader will lead a team of managers who establish, maintain, and strengthen Quality processes to ensure compliance of product and systems to customer and regulatory requirements.


What will you do?

  • Provide Quality leadership by developing and empowering staff, encouraging relationships, putting staff in a position to succeed, meeting their personal career goals while also achieving organization goals.

  • Develop and coach the Quality team to provide the best possible service through effective communication, scientific leadership, and problem solving.

  • Lead a culture of quality ownership, collaboration, and compliance.

  • Build and maintain collaborative relationship with key partners in Operations, Business, Commercial, and other functions.

  • Be comfortable navigating a sophisticated functional and technical matrix.

  • Lead all aspects of quality metrics, performance reports, and customer concern resolution.

  • Drive operational performance by identification, monitoring, and trending of quality metrics.

  • Collaborate across functions and sites to troubleshoot problems, interpret data and resolve next steps based on risk-based approach.

  • Provide guidance and direction to ensure ISO/Quality Management System compliance.

  • Design, plan and lead Practical Process Improvements (PPI) initiatives focusing on scientific practices, knowledge, standard work, or quality initiatives.

How will you get here?

Education

  • Bachelor of Science (B.Sc) from an accredited college/university in Science, Engineering, Biochemistry, Biotechnology, Microbiology, or Biomedical Engineering.
  • Advanced degree in Business/Management preferred.

Experience

  • Proven ability in a Quality Assurance position within the Chemical, Medical Device or Pharmaceutical Industries supporting Regulated Products.
  • Strong leadership experience ideally at multisite level gained within a manufacturing environment
  • Experience with ISO 9001, Good Manufacturing Practices, ISO 13485 and compliance with Medical Devices or Pharmaceutical products (ICH, 21 CFR 211, MDSAP, FDA 21 CFR Part 820).
  • Knowledge, Skills, Abilities (Required)
  • Proven experience in developing managers and teams.
  • Experience leading conversations with customers and auditors.
  • Ability to think strategically with the capability to advise the resolution of technical problems using innovative ways.
  • Work with diverse teams, guide teams through decision making, facilitate agreement, build collaborative relationships, and focus on customer needs.
  • Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
  • Highly skilled in Quality tools e.g. FMEA, Risk Analysis, Root Cause Analysis.]

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.

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255.

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