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Thermo Fisher Scientific · 1 day ago

Manager, Quality

North Carolina, United States

Full-time

Onsite

Senior Level

7+ years exp

Thermo Fisher Scientific is a leading contract development and manufacturing organization offering end-to-end services for drug development. The Manager, Quality will oversee the implementation of a Quality Risk Management Program, ensuring effective processes across multiple sites and regulatory compliance.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

Responsibilities

Provide leadership and guidance for installing an effective global Quality Risk Management program

Implement the Quality Risk Management Program Roadmap and Risk Maturity Model, and support execution of corresponding Gap Assessments

Work with different support functions business partners to manage key elements (e.g., Leadership, Program + Tools, Training, Culture) contributing to an effective Quality Risk Management installation

Partner and collaborate with the different Global Quality Systems groups (e.g., Supplier Quality, Digital Quality Systems, Lab Systems & Technology, Quality Operations, Global Compliance, Quality Academy, and Quality Assurance Systems) from a Quality Risk Management standpoint

Identify, facilitate, and implement continuous improvement projects related to Quality Risk Management processes and systems thru the adoption of Practical Process Improvement (PPI) Business System

A Quality Risk Management SME

Serve as a Lead / SME in Quality Risk Management governance processes

Leverage Quality Risk Management practitioners across the network to support sites in the region

Ensure risk assessments are conducted at required intervals and frequencies

Manage the global Risk Register process / program

Actively contribute in the Community of Practice

Provide Quality Risk Management training

Implement 'Pilot' type of initiatives directly or indirectly related to the Quality Risk Management program

Up to 25% travel required

Qualification

Quality Risk ManagementPharma/Biopharma ExperienceProject ManagementContinuous ImprovementMicrosoft Office SuiteCommunication SkillsIndependent WorkPresentation Skills

Required

Bachelor's Degree or higher in Chemistry, Biochemistry, Engineering, or other physical science degrees with relevant work experience

Minimum of 7 years' experience in pharma/biopharma regulated industry (GxP) with strong direct hands-on pharmaceutical experience in Quality Risk Management processes, QA, Operations, Technical Services, R&D, or a combination, with a minimum of 4 years' validation experience

Strong project management experience with ability to work in matrix / remote environment

Proven Project Management experience

Ability to prioritize multiple tasks across a portfolio of projects

Ability to drive continuous improvement / operational excellence

Ability to work independently with little supervision, especially remotely

Proficiency in Microsoft Office Suite (Teams, Word, Excel, PowerPoint, etc.)

Ability to communicate via web-based conferencing / collaboration platforms

Strong written and verbal communication skills and effective presentation skills

Ability to influence peers and Quality Risk Management practitioners to overcome common pitfalls & paradigms (e.g., 'one-off' activity, an additional task, 'gray' area, not adding new value) thru the practical adoption of effective Quality Risk Management

Must be legally authorized to work in the United States now and in the future, without sponsorship

Must be able to pass a comprehensive background check, which includes a drug screening