Quality Assurance Manager I

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

QA Manager I

The QA Manager I role has a national salary range of $85,000- $150,000.

DHL Supply Chain offers multiple benefits including Medical, Dental, Vision, Prescription, Discounted Stock Purchase, General Bonus Plan and a generous PTO policy.

Are you looking for a challenging and rewarding opportunity in a fast-paced environment? Do you take an analytical approach to design complex and innovative solutions that exceed customer expectations and directly impact a growing business? Do you enjoy being part of a passionate team that works with stakeholders from across the business to create and implement the best solutions for our customers?

Job Description

Manage and coordinate all aspects of quality assurance activities with various levels of risk and complexity within a variety of scopes across a single site / multiple sites and / or single or multiple customers . Confirm requests for quality support from the site and communicate policies and procedures. Expert regarding selected governmental regulations for the site(s). Proactive liaison with customer for quality assurance across site(s). Develop, manage, and oversee site quality resources. Support global and cross-sector Quality and Regulatory initiatives, as required. Support validated processes as applicable for regulated hardware, equipment, and software systems.

• 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

Required Education and Experience

• Bachelor Degree or equivalent 4 years work experience, required
• Certification related to quality control, preferred
• 3+ years experience in a regulated environment OR ISO 9001 compliant or certified, required
• 1+ years of supervisory or management experience, required
• Manufacturing, Food, Life Sciences, or 3PL Industry experience, required
• Participation in successful standards organization registration in a complex environment
• Supervising or implementing quality control programs
• Knowledge of regulations such as FDA, GxPs, ATF, DEA, etc.
• Administrator of training in compliance to regulated standards
• People development
• People management
• Process development
• Sufficient computer application experience
• Strong written and verbal communication
• Data analysis experience
• Training and facilitation skills
• Self management
• Problem solving
• Project management
• Presenting
• Report creation
• Solution execution

Our Organization is an equal opportunity employer.