QA Manager II

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.

Responsibilities

• 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’s degree in a related field or 1+ years relevant work experience
• Less 5+ years of relevant experience in a regulated environment (e.g. FDA USA, Health Canada, etc) or ISO 9001 (or industry equivalent) compliant or certified
• 3-5 years of supervisory or management experience (preferably supervising/managing a quality system in a complex/matrix organization)

Our Organization has a business casual environment and focuses on teamwork, associate development, training, and continuous improvement. We offer competitive wages, excellent affordable insurance benefits (including health, dental, vision and life), 401K plan, paid vacation and holidays.

Our Organization is an equal opportunity employer.

This posting is for the Multi-Client Healthcare Manchester, PA location.