Quality Assurance Manager I

About the role

Are you looking for a challenging and rewarding opportunity in a fast-paced environment? Do you take an analytical approach to design complex and innovative solutions that exceed customer expectations and directly impact a growing business? Do you enjoy being part of a passionate team that works with stakeholders from across the business to create and implement the best solutions for our customers?

Responsibilities

• 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.

Qualifications

• 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

Skills

• 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

Pay

National salary range of $85,000 – $150,000.

Benefits

• Medical
• Dental
• Vision
• Prescription
• Discounted Stock Purchase
• General Bonus Plan
• Generous PTO policy