Quality Assurance Manager I

DHL (Supply Chain)•Channahon, IL

4d•$85,000 - $150,000•Onsite

About The Position

The Quality Assurance Manager I manages and coordinates quality assurance activities of varying risk and complexity across one or more sites and customers. The role confirms site requests for quality support, communicates policies and procedures, serves as an expert on selected governmental regulations, and acts as a proactive quality assurance liaison with customers. The manager develops and oversees site quality resources, supports global and cross-sector quality and regulatory initiatives, and supports validated processes for regulated hardware, equipment, and software systems as applicable. The position oversees the maintenance and continuous improvement of the quality system, regulatory compliance, licenses and registrations, validation and change control, associate training and development, audit activities, supplier quality, and quality metrics. It also supports continuous improvement, prepares management reports, serves as a primary customer contact for quality matters, and provides business development support and representation at customer events and meetings as needed.

Requirements

Bachelor's degree or equivalent to four years of work experience.
At least 3 years of experience in a regulated environment or an ISO 9001-compliant or certified environment.
At least 1 year of supervisory or management experience.
Experience in Manufacturing, Food, Life Sciences, or the 3PL industry.
Participation in successful standards organization registration in a complex environment.
Experience supervising or implementing quality control programs.
Knowledge of regulations such as FDA, GxPs, ATF, or DEA.
Experience administering training in compliance with regulated standards.
People development and people management skills.
Process development skills.
Sufficient computer application experience.
Strong written and verbal communication skills.
Data analysis experience.
Training and facilitation skills.
Self-management, problem-solving, and project management skills.
Presentation, report creation, and solution execution skills.

Nice To Haves

Certification related to quality control.

Responsibilities

Manage and coordinate quality assurance activities across one or more sites and customers, addressing requests for quality support and communicating policies and procedures.
Serve as an expert on selected governmental regulations applicable to the site or sites and as a proactive customer liaison for quality assurance.
Develop, manage, and oversee site quality resources; hire, train, and develop quality associates.
Support global and cross-sector Quality and Regulatory initiatives and validated processes for regulated hardware, equipment, and software systems as applicable.
Oversee maintenance and continuous improvement of the quality system, including management review, CAPA management, internal audits, self-assessments, change control, document control, and standard operating procedures and work instructions.
Oversee the licenses, permits, and registrations process.
Assess regulatory compliance for products handled and services performed against applicable cGxP, contracts (OSA, QAA/TA), and customer requirements, and report results to executive management.
Ensure systems and equipment are validated when applicable and that change control processes are maintained.
Monitor site associate training and development to ensure compliance with processes and regulations.
Coordinate with the continuous improvement team to focus and direct improvement activities and workshops.
Review regulatory, customer, and third-party audits and provide recommendations.
Review quality assurance metrics and identify organizational trends.
Serve as the primary customer contact for quality-related issues and initiatives as needed.
Develop, distribute, and maintain regular management reports.
Manage site suppliers and prepare for, receive, and act on audits.
Provide business development support and represent DHL at customer events and meetings as required.