Head of Quality Assurance

3 weeks ago

Peachtree City GA, Fayette County, GA, United States Gerresheimer Full time
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.

Job Description
  • Ensuring the product quality defined in terms of quality through introduction, Implementation and support of quality assurance measures
  • Personnel management with all included individual tasks (disciplinary
  • initiate measures, assess employees, personnel development, etc.)
  • Ensuring the induction, assessment and further development of employees by the subordinate managers
  • Identify problems and point out possible solutions
  • Introduce and use quality assurance tools and techniques (e.g.
  • FMEA, statistical methods, etc.)
  • Introduce problem solutions or optimizations and track their effectiveness
  • Ensuring the necessary quality documentation (e.g. as part of the
  • change controls, validations, etc.)
  • Responsibility for the planning, implementation and follow-up of internal
  • and external audits as well as official inspections
  • Independent assurance of effective interface communication
  • (internal/external)
  • Proactive cooperation with internal and external interfaces (e.g.
  • plant management, production areas, HR, customers) as well as with sister plants
  • Responsible for continuous improvement (technology and
  • organization of work) in their own area
  • Cost center responsibility
  • Independent assumption of project tasks in the QA environment


Qualifications
  • Knowledge, as required within the framework of a minimum 3-year technical.(professional) University degree and at least 5 years of experience in the field of Quality management with managerial responsibility were acquired and deepened.
  • This function requires special knowledge in the field of quality managementin the field of pharmaceutical and medical products.
  • Advanced knowledge of quality management, including methods and guidelines(e.g., GMP) and responsibility for budget, costs and personnel
  • Expert knowledge in personnel management and qualification
  • Expert knowledge of the relevant standards and QM guidelines according to current valid qualification matrix
  • Very good knowledge in the areas of resource and deployment planning
  • Very good knowledge of quality management systems
  • Good written and spoken English knowledge
  • Good IT user skills (e.g., MES / SAP, MS Office)
  • Strong leadership motivation, including the necessary skills (role model function, integrity, transparency, appreciation)
  • Excellent communication skills (multiple / complex)
  • High performance and organizational motivation
  • Distinctive action orientation, conscientiousness and flexibility
  • Confident demeanor, sensitivity and ability to communicate
  • Sociability and team orientation
  • Emotional stability, resilience and self-confidence
  • Very highly developed entrepreneurial thinking and acting
  • Performance management (KPIs, performance/goal control, define definitions)
  • Moderation and conduct of negotiations
  • Knowledge of organizational development measures
  • Knowledge of problem-solving methods (KT, Six Sigma, etc.)
  • Application of quality methods (FMEA, Ishikawa, Lean, CIP, etc.)


Additional Information
  • Monday - Friday
  • company health benefits, 401k, incentive bonuses

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