Quality Systems Manager Position Available In Mecklenburg, North Carolina

Quality Systems Manager Imperium Life Sciences Charlotte, NC Job Details Full-time $80,000 – $122,000 a year 16 hours ago Benefits Health insurance Dental insurance 401(k) 401(k) matching Life insurance Qualifications 5 years Engineering

ISO 9001

Project management Bachelor’s degree Logistics quality assurance Total Quality Management Senior level Project leadership Leadership FDA regulations Full Job Description Manager of Quality Systems $80,000 – $122,000 Monday to Friday 9am-5pm Pharmaceutical manufacturing Start date: ASAP I’m working with a Pharmaceutical Manufacturing company who are on the lookout for a Manager of Quality Systems to join their team in Charlotte North Carolina. This is a medium sized pharmaceutical company, but they are investing heavily in their staff and their infrastructure to be able to grow into a well-known household brand. This company already has a global presence and works with a wide array of clients themselves. These vary from small startups to some of the biggest names in the world, and you could be a part of this growing company. If you want to become a part of a team that invests in it’s staff to improve the overall company, that has clear paths of progression to promotions and a company that has committed to an impressive amount of growth in the next 5 years then this could be the company for you.

What You’ll Be Doing:

As the Quality System Manager, you’ll take the lead in making sure our Quality Management System (QMS) runs smoothly, meets all the necessary regulations, and helps us keep improving how we work and the quality of our products. You’ll focus on managing our electronic quality system (eQMS), handling CAPAs, overseeing change control, and keeping our audit program on track.

Your Key Areas of Focus:

1. eQMS (Electronic Quality Management System): Manage the setup, upkeep, and ongoing improvements of the eQMS so we stay in line with all regulatory requirements. Handle document control—making sure procedures (SOPs) and other key documents are reviewed, approved, and up-to-date. Work with document owners to create clear, efficient processes that work well across teams. 2. CAPA (Corrective and Preventive Actions): Lead the CAPA process, making sure investigations are thorough, root causes are identified, and actions are completed on time. Run CAPA review meetings to keep things moving and share progress with leadership. Check that completed CAPAs actually work and prevent repeat issues. 3.

Change Control:

Oversee all change control activities—ensuring changes are clearly documented, properly assessed for risk, and rolled out in line with our QMS. Help teams across the company follow a consistent and effective approach to managing changes. 4.

Quality Compliance & Continuous Improvement:

Make sure our quality system meets

FDA, ISO

13485, and

ISO 9001

requirements. Spot opportunities to improve our systems and processes—and help make those improvements happen. Lead training sessions and mentor staff on how to handle CAPAs, audits, and change controls effectively.

What We’re Looking For:

• A bachelor’s degree in Engineering, Life Sciences, or something similar (a higher degree is a plus).
• 5-8 years of experience in the medical device world, with a strong background in QMS, CAPAs, audits, and regulatory compliance (ISO 13485, 21 CFR 820).
• Hands-on experience setting up and managing eQMS tools—bonus points if you’ve worked with MasterControl.
• Proven leadership and project management skills, especially in quality system oversight.
• A deep understanding of FDA and ISO requirements, and confidence in leading compliance initiatives.

Job Type:

Full-time Pay:

$80,000.00 – $122,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance

Schedule:

8 hour shift

Work Location:

In person