Quality Assurance Manager I

DPDHL•China Grove, NC

11d•$85,000 - $150,000•Onsite

About The Position

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

Requirements

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

Nice To Haves

Certification related to quality control, preferred

Responsibilities

Manage and coordinate all aspects of quality assurance activities
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
Oversee the licenses, permits, and registrations process
Manage and provide oversight for regulatory compliance
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
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