Manager, Quality

Thermo Fisher Scientific
Wilmington, NC
Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join our Pharma Services team and be a part of a leading contract development and manufacturing organization (CDMO) offering end-to-end services for drug development, clinical trial logistics, and commercial manufacturing! Biotech and biopharma companies trust us for our speed, flexibility, and quality across every phase of drug development. With worldwide locations, we support active pharmaceutical ingredients (APIs), biologics, cell therapy, viral vectors, formulation, clinical trials, logistics, commercial manufacturing, and packaging. Help us enable many major therapies on the market today and drive the future of healthcare!

Description

How will you make an impact By executing key deliverables for the implementation of a practical, proactive, sustainable, scalable, and effective Quality Risk Management Program within the Pharma Services Group. Must be highly organized with an ability to multi-task, work and communicate across multiple sites, different business units, and functions, encompassing the full product life cycle, from early product & process development through commercial manufacturing. Will assist in developing and deploying global processes and systems that must effectively work for multiple sites and will ensure and facilitate their adoption while using industry standard methodologies and body of knowledge and, incorporating different requirements and expectations from various regulatory bodies. The position will be in the Global Quality Systems - Quality Operations Team and will report to the Director of Quality Risk Management.

What You Will Do

  • 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

How You Will Get Here

Education

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

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.

Knowledge, Skills, Abilities

  • 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.

Excellent Benefits

  • Benefits & Total Rewards | Thermo Fisher Scientific (
  • Medical, Dental, & Vision benefits-effective Day 1
  • Paid Time Off & Designated Paid Holidays
  • Retirement Savings Plan
  • Tuition Reimbursement

Other

  • Relocation assistance is NOT provided
  • 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

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.
Posted 2026-01-15

Recommended Jobs

Beauty Advisor - Part Time - Streets at Southpoint

L'Occitane En Provence
Durham, NC

Who You Are: Embark on a serene journey as a Beauty Host with L’Occitane. Our Beauty Hosts immerse your senses in the warmth of Provence through personalized beauty moments. Our goal is to for…

View Details
Posted 2026-01-12

Project Manager II - Professional Services

FIS
Charlotte, NC

care was taken to include all competencies needed to successfully perform in this position. However, for Americans with Disabilities Act (ADA) purposes, the essential functions of the job may or may n…

View Details
Posted 2026-01-14

Dental Assistant

Heartland Dental
Burlington, NC

Dental Care at Alamance Crossing is looking for a Dental Assistant with 1+ years of experience to join our team. The ideal candidate will have experience with ortho, endo and surgery procedures. M…

View Details
Posted 2025-12-25

Assistant Director of Nursing (Home Infusion) -Greenville, NC

Greenville, NC

Why Join Us? This is a growing Home Infusion company that is opening a new location in Seattle, WA! You will have the opportunity to make a contribution to our joint success on a daily basis. We…

View Details
Posted 2025-12-09

Flooring Installer

Refloor
Raleigh, NC

Flooring Installer Make more with Refloor. Earn $3,000-$6,000 per week ($156,000 - $312,000 per year).  Take your income to the next level! At Refloor, growing your earnings has never been easie…

View Details
Posted 2026-01-15

Construction Technician

Paul Davis Restoration of the National Capital Region, VA
Winston Salem, NC

Responsive recruiter Benefits ~401(k) ~401(k) matching ~ Competitive salary ~ Flexible schedule ~ Health insurance ~ Opportunity for advancement ~ Paid time off ~ Vision insurance …

View Details
Posted 2025-12-29

Travel Cardiac Telemetry RN - $2,083 per week

HealthTrust Workforce Solution External
Hickory, NC

HealthTrust Workforce Solution External is seeking a travel nurse RN Telemetry for a travel nursing job in Hickory, North Carolina. Job Description & Requirements ~ Specialty: Telemetry ~ Dis…

View Details
Posted 2026-01-14

Manager, Ontology and Data Modeling - Commercial Bank

Capital One
Charlotte, NC

Manager, Ontology and Data Modeling - Commercial Bank The role of the Manager of Ontology and Data Modeling is to develop, implement, and maintain enterprise ontologies in support of Capital …

View Details
Posted 2026-01-05

Assistant Community Manager - Mosaic South End

Greystar
Charlotte, NC

ABOUT GREYSTAR Greystar is a leading, fully integrated global real estate platform offering expertise in property management, investment management, development, and construction services in ins…

View Details
Posted 2026-01-02

Laser Tag Referee at Battle House

Battle House Laser Tag
Wake Forest, NC

Exciting Opportunity : Laser Tag Referee at Battle House Laser Tag in Wake Forest, NC.  Are you tired of the same old routine jobs such as restocking shelves or standing over a fryer all day? Em…

View Details
Posted 2025-12-01