Quality Assurance Manager I: Regulated Systems Lead

Joinimagine; Mississippi; On-site; USD 85,000 - 150,000; Full time

Job summary

Joinimagine is seeking a QA Manager I to lead quality assurance across sites, ensuring compliance with cGxP, FDA and other regulations while driving CAPA, audits, and continuous improvement. The role partners with stakeholders to design robust quality systems.

You will hire and develop QA staff, review metrics, manage supplier audits, and provide regular reports to leadership. A Bachelor's degree and 3+ years in regulated environments are required; experience in manufacturing, life sciences, or

Qualifications

• Bachelor Degree or equivalent 4 years of work experience required.
• 3+ years in a regulated environment or ISO 9001 compliant.
• 1+ years of supervisory or management experience.
• Manufacturing, Life Sciences, or 3PL industry experience preferred.
• Knowledge of FDA, GxPs, ATF, DEA regulations.
• Strong data analysis and problem-solving skills.
• Excellent written and verbal communication.

Responsibilities

• Oversee the maintenance and continuous improvement of the overall quality system, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and standard operating procedures/work instructions.
• Oversee the licenses, permits, and registrations process.
• Manage and provide oversight for regulatory compliance with regards to products handled and services performed at site by assessing performance to cGxP, the contract (OSA, QAA/ TA), and customer requirements as applicable; reporting the results to executive management
• Ensure that systems and equipment are validated (if applicable) and change control processes maintained
• Hire, train, and develop quality associates.
• Monitor the training and development of site associates to ensure compliance to processes and regulations.
• Work in coordination with continuous improvement team to focus/direct continuous improvement activities/workshops
• Review and provide recommendations on regulatory, customer and 3rd party audits.
• Review and identify trends within the quality assurance metrics for the organization.
• Primary customer contact for QA related issues/initiatives as needed.
• Develop, distribute and maintain regular management reports
• Manage site suppliers and prepare, receive, and act on audits
• Provide Business Development support and represent DHL in customer events and meetings as required

Skills

Quality assurance

Regulatory knowledge

Data analysis

Project management

Leadership

Communication

Education

Bachelor's degree or equivalent

Quality assurance certification

Job description

Joinimagine is seeking a QA Manager I to lead quality assurance across sites, ensuring compliance with cGxP, FDA and other regulations while driving CAPA, audits, and continuous improvement. The role partners with stakeholders to design robust quality systems.

You will hire and develop QA staff, review metrics, manage supplier audits, and provide regular reports to leadership. A Bachelor's degree and 3+ years in regulated environments are required; experience in manufacturing, life sciences, or