Quality Assurance Manager I
About The Position
The QA 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. It 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 manager oversees the quality system and its continuous improvement, regulatory compliance, licenses and registrations, validation and change-control processes, audits, quality metrics, site suppliers, and management reporting. The position hires, trains, and develops quality associates; supports continuous improvement activities; serves as a primary customer contact for quality matters; and provides Business Development support, including representing DHL at customer events and meetings as required.
Requirements
- Bachelor’s degree or equivalent work experience of four years.
- 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.
- Experience administering training for compliance with regulated standards.
- People development and people management capabilities.
- Process development capability.
- Sufficient computer application experience.
- Strong written and verbal communication skills.
- Data analysis experience.
- Training and facilitation skills.
- Self-management, problem-solving, project management, presentation, report creation, and solution execution skills.
Nice To Haves
- Certification related to quality control.
Responsibilities
- Manage and coordinate quality assurance activities across a single or multiple sites and customers, including confirming requests for quality support and communicating policies and procedures.
- Serve as an expert on selected governmental regulations for the site or sites and as a proactive quality assurance liaison with customers.
- Develop, manage, and oversee site quality resources; support global and cross-sector Quality and Regulatory initiatives; and 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 management, internal quality audits, quality self-assessments, change control, document control, and standard operating procedures and work instructions.
- Oversee the licenses, permits, and registrations process.
- Manage and oversee regulatory compliance for products handled and services performed at the site, assessing performance against cGxP, contracts (OSA, QAA/TA), and customer requirements as applicable, and reporting results to executive management.
- Ensure systems and equipment are validated when applicable and that change-control processes are maintained.
- Hire, train, and develop quality associates; monitor site associate training and development to ensure compliance with processes and regulations.
- Coordinate with the continuous improvement team to focus and direct continuous improvement activities and workshops.
- Review regulatory, customer, and third-party audits and provide recommendations.
- Review and identify trends in organizational quality assurance metrics.
- Act as the primary customer contact for QA-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.
Benefits
- Medical, dental, vision, and prescription benefits.
- Discounted stock purchase.
- General Bonus Plan.
- Generous PTO policy.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
