Senior QA Manager - Regulated Quality & Compliance

DHL Group; Bethlehem (Northampton County); Presencial; USD 70.000 - 115.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical

Dental

Vision

Prescription

Discounted stock purchase

General Bonus Plan

Generous PTO

Descripción de la vacante

DHL Supply Chain is seeking a QA Manager II to oversee quality assurance activities across a site, drive CAPA, audits, and regulatory compliance in a fast-paced environment. The role leads QA staff, ensures GMP/GxP adherence, and partners with customers to meet quality expectations.

Responsibilities include maintaining the quality system, conducting internal audits, managing training, and delivering regular quality metrics and reports to stakeholders to support continuous improvement and

Formación

• 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

Responsabilidades

• Oversee 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

Conocimientos

Quality Assurance

Regulatory compliance

Audits

Data analysis

Training and facilitation

Project management

People management

Leadership

Educación

Bachelor Degree or equivalent

Quality control certification

Descripción del empleo

DHL Supply Chain is seeking a QA Manager II to oversee quality assurance activities across a site, drive CAPA, audits, and regulatory compliance in a fast-paced environment. The role leads QA staff, ensures GMP/GxP adherence, and partners with customers to meet quality expectations.

Responsibilities include maintaining the quality system, conducting internal audits, managing training, and delivering regular quality metrics and reports to stakeholders to support continuous improvement and