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Thermo Fisher Scientific Global Quality Systems Manager in Boston, Massachusetts

Global Quality Systems Manager

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location:

US - Remote

How you will make an impact?

Executes key project deliverables related to the Insightful Investigations project. The project aims to gain quality benefits through robust investigations that are right the first time, reducing the compliance risk and avoiding recurrence. The business benefit of the project is investigation cycle time reduction to support on-time product delivery and customer satisfaction.

What will you do?

  • Performs diagnostic of site investigations against the investigation rubric.

  • Evaluates diagnostic results to identify improvement opportunities and advise on remedial actions.

  • Coordinates and performs deviation training for the network.

  • Supports the execution of the site deviation owners and approver qualification plan.

  • Monitors and develops monthly reports related to site improvement strategy.

  • Lead or assists with continuous improvement initiatives related to deviation investigation training materials, global quality documents and process.

  • Leads or assists with the facilitation of the Investigation Forum and other Global Community of Practice initiatives for investigation practitioners within the network.

  • Develops reports and metrics.

How will you get there?

Education:

  • Bachelor’s degree in biological science or a related field preferred

Experience:

  • Minimum 6 years of experience with investigations in the pharmaceutical industry.

  • Experience with TapRooT, Operational Excellence, Project Management, Training and Human Performance is preferred.

  • Equivalent combinations of education, training and relevant work experience may be considered.

Knowledge, Skills and Abilities:

  • Exceptional Good Manufacturing Practices, Good Laboratory Practices, International Conference on Harmonization (ICH) and United States Food and Drug Administration (FDA) compliance knowledge.

  • Ability to drive functional, technical and operational excellence. Excellent analytic, leadership and communication skills.

  • Advanced organization and project management skills.

  • Ability to travel internationally (up to 35%) to provide support to sites with investigation training, ability to work in a fast paced environment.

  • Experience with Microsoft Office Applications. Proficiency in the English Language.

Standards and Expectations:

Follow all Environmental Health & Safety Policies and Procedures. Work harmoniously with fellow team members, modeling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, shared laboratory assets). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engaging in problem-solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identifies areas for improvement in the execution of analytical procedures. Communicate risks to timelines of deliverables in a proactive manner. Consistently strives to improve skills and knowledge in pharmaceutical development.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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.

Accessibility/Disability Access

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*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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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