Quality Manager
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: North Carolina • United States
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About the role
- 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
Requirements
- 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.
Benefits
- Medical, Dental, & Vision benefits-effective Day 1
- Paid Time Off & Designated Paid Holidays
- Retirement Savings Plan
- Tuition Reimbursement
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality Risk ManagementGap AssessmentsContinuous ImprovementPractical Process ImprovementProject ManagementValidationQuality AssuranceOperationsTechnical ServicesResearch and Development
Soft skills
LeadershipCollaborationCommunicationInfluencingPrioritizationIndependencePresentation SkillsOrganizational SkillsProblem SolvingAdaptability