Quality Assurance Manager I

DHL Supply Chain•Channahon, IL

3d•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 and communicates quality support requests, policies, and procedures; serves as an expert on selected governmental regulations; and acts as a proactive quality assurance liaison with customers. It develops and oversees site quality resources and supports global and cross-sector Quality and Regulatory initiatives, including validated processes for regulated hardware, equipment, and software where applicable. The position oversees the quality system and its continuous improvement, including management reviews, CAPA management, internal audits, self-assessments, change control, document control, and standard operating procedures and work instructions. It manages licenses, permits, and registrations; oversees regulatory compliance for products and services; and reports compliance results to executive management. The role also oversees validation and change control for systems and equipment where applicable, hires and develops quality associates, coordinates training compliance, and works with continuous improvement teams. Additional duties include reviewing audits and quality metrics, serving as a primary customer contact for quality issues and initiatives, producing management reports, managing site suppliers and audits, and supporting business development and customer events. DHL Supply Chain describes the role as an opportunity to work in a fast-paced environment with stakeholders across the business.

Requirements

Bachelor’s degree or equivalent.
At least 4 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 the manufacturing, food, life sciences, or 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, and DEA.
Ability to administer training for 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, handling requests for support and communicating applicable policies and procedures.
Serve as an expert regarding selected governmental regulations and as a proactive quality assurance liaison with customers.
Develop, manage, and oversee site quality resources and support global and cross-sector Quality and Regulatory initiatives.
Support validated processes for regulated hardware, equipment, and software systems as applicable.
Oversee maintenance and continuous improvement of the quality system, including management reviews, CAPA, internal audits, self-assessments, change control, document control, and SOPs and work instructions.
Oversee licenses, permits, and registrations.
Oversee regulatory compliance for products handled and services performed at the site, assessing performance against applicable cGxP, contracts, and customer requirements, and reporting results to executive management.
Ensure applicable systems and equipment are validated and change control processes are maintained.
Hire, train, and develop quality associates, and monitor site associate training and development for compliance with processes and regulations.
Coordinate with the continuous improvement team to focus and direct continuous improvement activities and workshops.
Review and recommend actions concerning regulatory, customer, and third-party audits.
Review quality assurance metrics and identify organizational trends.
Act as the primary customer contact for quality assurance 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.