Head of Quality Assurance

Company Description

Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 11,000 employees and generated annual revenues in 2022 of EUR 1.8bn. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

Gerresheimer Peachtree City L.P. was established in 1993 in Peachtree City, GA, as part of the Plastics & Devices Division manufacturing and assembling a variety of precision molded plastic parts for various applications in the medical industry. The subsidiary operates in an 87,500 sq. ft. production facility with 200 employees. 

• Ensure product quality standards are met by implementing, monitoring, and supporting quality assurance measures across the production process.
• Lead and manage personnel, including disciplinary actions, performance evaluations, and fostering employee development.
• Oversee the onboarding, evaluation, and ongoing development of team members through subordinate managers.
• Identify and address quality issues, providing actionable solutions to resolve problems efficiently.
• Implement and utilize quality assurance tools and techniques (e.g., FMEA, statistical methods) to drive improvements.
• Propose and implement problem-solving strategies and optimizations, tracking their effectiveness over time.
• Ensure accurate and thorough quality documentation, including change controls, validations, and other compliance-related processes.
• Plan, execute, and follow up on internal and external audits as well as official inspections, ensuring all standards are met.
• Foster effective communication and collaboration across internal and external interfaces, including plant management, production teams, HR, customers, and sister plants.
• Lead initiatives for continuous improvement within your department, focusing on both technological advancements and organizational efficiency.
• Manage the cost center, ensuring effective budgeting and resource allocation.
• Independently take on and manage project tasks within the Quality Assurance environment.

• Bachelor’s degree in a technical or related field, with a minimum of 5 years of experience in Quality Management, including managerial responsibility.
• Specialized expertise in quality management within the pharmaceutical and medical device sectors.
• Advanced knowledge of quality management principles, including methods and regulations (e.g., GMP), with responsibility for budgeting, cost control, and personnel management.
• Expertise in leadership and personnel development, with strong skills in team management and employee qualification.
• Comprehensive understanding of relevant standards and quality management guidelines based on the current qualification matrix.
• Strong proficiency in resource planning and deployment management.
• In-depth knowledge of quality management systems.
• Fluent in English, with strong written and verbal communication skills.
• Proficient in IT systems, including MES/SAP and MS Office.
• Demonstrates strong leadership motivation and essential leadership qualities, such as integrity, transparency, and respect.
• Excellent communication skills, with the ability to manage complex and multifaceted interactions.
• High levels of performance orientation and organizational skills.
• Action-oriented, conscientious, and adaptable to changing environments.
• Exhibits confidence, emotional stability, and resilience, with a self-assured approach to challenges.
• Highly developed entrepreneurial thinking and the ability to drive business success.
• Proven experience in performance management, including KPI management, goal-setting, and performance tracking.
• Expertise in negotiation and facilitation.
• Knowledgeable in organizational development strategies.
• Proficient in problem-solving methodologies such as KT and Six Sigma.
• Experienced in applying quality assurance tools, including FMEA, Ishikawa, Lean, and continuous improvement processes (CIP).

Your contact person: Gabrielle Holland (gabrielle.holland@gerresheimer.com)

All your information will be kept confidential according to EEO guidelines.