41 days ago on edelweisshr.ch

Head of Quality Department (w/m)

Edelweiss HR Services

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Head of Quality Department (w/m)

Job Type: 
Full Time
Job Category: 
Life Science

Edelweiss HR is specialized on the placement of high-quality candidates, permanent staffing solutions for companies with HQ in Europe. On behalf of our client, an international life science company, we are looking for a motivated personality as:

Head of Quality Department (w/m)

• To lead and manage the operational and strategic performance of the Quality Department of the Company Group, supporting the successful delivery of business strategy, key performance indicators (KPIs) and objectives, whilst enabling the group companies to adhere to regulatory compliance and achieving commercial success
• To ensure the efficient and effective day to day running of the company Quality department
• The successful candidate will report directly to the CEO

• Developing and implementing the quality strategy of the Company Group, to ensure the group companies meet the regulatory requirements and customer deliverables, as well as ensuring the performance of the group companies against goals
• Implementing, maintaining and monitoring all quality systems in the group companies to ensure compliance with applicable norms (ISO9001, ISO17025) and with EU Commission Directive 2003/94/EC, covering GMP for medicinal products for human use and investigational medicinal products (IMPs)
• Implementing and maintaining a risk management system to ensure that risks are adequately controlled in accordance with current requirements (ISO norms, EU GMP Part III Q9)
• Acting as the main point of contact on all quality matters, internally (group companies), externally (clients) and authorities
• Coordinating the inspections by authorities and audits by clients, and group internal audits
• Improving and facilitating operational interactions of the group companies, to meet the requirements of customers, with respect to quality, service, lead time and cost
• Ensuring that there is a program for the qualification of suppliers and subcontractors serving all group companies and that the required audits are performed and reported as scheduled
• Developing a qualification/validation strategy for the group and thus enabling the group companies to manage all qualification/validation activities in a harmonized way
• Maintaining an awareness of new and proposed legislation and regulation that impact the business and communicating any changes to the group management
• Ensuring adequate quality resource in the group companies to provide quality oversight and certification for the services and products provided

Required skills:
• Technical or scientific degree (ideally pharmacy,  biology, biochemistry, chemistry or similar)
• Demonstrated experience gained within a similar position
• Background and experience in operations
• Proven GMP experience absolutely essential
• Strong leadership/team management skills and experience
• Excellent project management skills
• Strong analytical and problem solving ability, hands-on approach with a “can do” attitude
• Self-motivated, positive thinking and self-confident
• Ready to make decisions and take actions
• Accessible to co-workers and clients with persuasive power
• Entrepreneurial understanding of business critical aspects
• Ability to approach people and establish a good network
• Good communication skills in English and German, French desirable
• Experience with LEAN-implementation in operations and a Quality environment is an asset

If you want to become part of a very team-oriented and dynamic organization where your contribution will be recognized and rewarded, please apply online.