Quality Assurance Manager II

DHL Germany; North Las Vegas (NV); On-site; Confidential; Full time

Benefits offered by this job

Medical

Dental

Vision

Prescription coverage

Stock Purchase

Bonus Plan

PTO

Job summary

DHL Supply Chain is seeking a QA Manager II to lead site QA operations, coordinate CAPA, audits, and compliance with regulatory standards. You will supervise QA staff, drive continuous improvement, and ensure robust quality systems across the site to meet customer requirements.

Responsibilities include managing quality metrics, coordinating with regulatory bodies, and serving as the primary QA liaison for customers. A Bachelor's degree and 3+ years in a regulated environment are required.

Qualifications

• Bachelor Degree or equivalent (4 years) required.
• Certification related to quality control preferred.
• 3+ years in a regulated environment or ISO 9001 compliant environment required.
• 1+ years of supervisory or management experience required.
• Manufacturing, Food, Life Sciences, or 3PL Industry experience required.
• Experience with standards registration in complex environments and training programs.

Responsibilities

• Oversee quality system maintenance, CAPA, audits, change control, and SOPs.
• Oversee regulatory licenses, permits, and registrations processes.
• Ensure compliance with FDA, GxPs, ATF, DEA, and customer requirements.
• Verify validation of systems and equipment and maintain change controls.
• Lead regulatory, customer, and 3rd party audits.
• Monitor training and development of site staff for compliance.
• Manage QA technicians and hire/train QA supervisors and specialists.
• Track quality metrics and report to executive management.
• Act as primary customer contact for QA initiatives.
• Develop and distribute regular management reports.
• Lead cross-functional continuous improvement projects.
• Ensure daily compliance with customer service and business standards.
• Plan and conduct inspections and standard confirmations on a daily basis.

Skills

Quality management

Data analysis

Problem solving

Project management

People management

Regulatory awareness

Communication skills

GxP knowledge

Education

Bachelor Degree or equivalent

ISO 9001 certification

Regulatory compliance training

Job description

The QA Manager II role has a national salary range of $70,000 - $115,000.

For roles within California the range is $70,304 - $115,000 and Washington is $80,169 - $115,000.

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

Would you like to join the Logistics Company for the World? DHL Supply Chain is just that.

Become an essential part of everyday life, by contributing to an organization that is Connecting People and Improving Lives. If you have a passion for people, a desire to problem-solve, and eagerness to pursue continuous improvement opportunities… we look forward to exploring career possibilities with you!

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. Confirm requests for quality support from the site and communicate policies and procedures. Proactive liaison with customer for quality assurance across site(s). Develop, manage, and oversee site quality resources. Support regional and sector QA and Regulatory Compliance 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 or a specific procedure, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and developing and maintaining standard operating procedures/work instructions.
• Oversee regulatory 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
• Lead key regulatory, customer and 3rd party audits.
• Monitor the training and development of site associates to ensure compliance to processes and regulations
• Manage Quality Technicians within the site, as applicable.
• Hire, train, and develop QA Supervisor, QA Specialist, QA Tech I, QA Tech II roles.
• Track and maintain quality assurance metrics for the organization.
• Act as primary customer contact for QA related issues/initiatives as needed.
• Track, monitor, and report quality assurance metrics for the site.
• Monitor the training and development of site associates to ensure compliance to processes and regulations
• Develop, distribute and maintain regular management reports.
• Lead and support cross functional continuous improvement projects/continuous improvement activities/workshops
• Ensure customer service and business standards requirements are met daily
• Plan, conduct, and act upon inspection processes- Gemba; Standards Confirmation etc on a daily basis

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 management
• 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.