Head of Quality (m/f/d)

Posted 2 Days Ago
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Skopje, Скопје, Skopski
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
The Head of Quality is responsible for managing the plant quality system in compliance with operational and regulatory standards. This role involves overseeing personnel management, project management in the quality management environment, conducting internal and external audits, and ensuring KPIs are met. The position also includes budget planning and acting as the Plant Quality Management Representative while fostering team development and inter-departmental collaboration.
Summary Generated by Built In

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. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

Job Description

  • Managing of the plant quality system in compliance with operational and regulatory requirements (ISO, GMP, etc.).
  • Proactive cooperation with internal and external interfaces (e.g. Production areas, Technical areas, Customers, Headquarter and sister plants)
  • Development of the area of responsibility efficiently and effectively
  • Personnel management of the area of responsibility with all included individual tasks (training and development plans, coordination of daily activities, feedback, appraisals, etc.)
  • Independent assumption of project management tasks in the QM environment
  • Monitoring of diligent execution of the processes under responsibility (validation, change control, CAPA, etc.)
  • Management of internal and external audits
  • KPI responsibility, ensuring reporting and measures for target achievement
  • Preparation of management reviews and follow-up from its resulting improvement measures
  • Budget planning in relation to personnel, work equipment, processes, etc. of the area of responsibility (e.g. OPSP, CAPEX)
  • Acting as Plant Quality Management Representative


Qualifications

  • Bachelor degree or above, preferable to major in Scientific, Engineering or related field, Six Sigma, Black Belt, Green Belt is a plus
  • Minimum of 5 years’ experience in Quality management in a manufacturing facility. Preferable to have injection molding plastic experience or medical device and / or pharmaceutical packaging products experience
  • Expertise in a clean room environment would be an advantage
  • Leaderships skill and experience in leading, qualifying and developing a team, acting as a as a role model for teamwork, integrity, responsibility, and excellence
  • Strong communication skills in different, multilateral and complex situations
  • Possesses intercultural sensitivity and understanding, with the ability to work collaboratively on an international business environment
  • Independent, proactive way of working and flexibility
  • Flexibility and resilience
  • Macedonian fluent (required), English fluent (required)
  • Further IT skills in e.g. MES, SAP, MSOffice


The Company
HQ: Düsseldorf
2,246 Employees
On-site Workplace
Year Founded: 1864

What We Do

Gerresheimer is the global partner for pharma, biotech, healthcare and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging and drug delivery devices. 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, focus on quality and customers. 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 10,000 employees and generates annual sales of more than €1.5 billion. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

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