Head of Microbiological Lab

Head of Microbiological Lab

Teva

Haarlem, Netherlands

The opportunity

You will be leading the Quality Microbiological Lab and you will be responsible for:

• Managing employees of the Laboratory (around 30 indirect reports and 4 direct reports);
• Managing the activities of the Microbiological laboratory (incl. raw materials, intermediate and end products testing, deviations, calibration and validation of equipment, method development, stability programs, cGXP, safety, budget);
• Coordinating with Quality Leadership as an active member of the Quality Management Team (incl. long-term local strategy, interaction on global platforms, translating global objectives into local objectives as well as sharing best practices);
• Representing the Site during regulatory authority inspections and from a quality perspective to customers, professional and trade organizations, the public and other external sources.

How you’ll spend your day

Manage Quality

• Lead the site's Analytical Microbiological laboratory team in establishing and maintaining quality at the lab in accordance with Site SOP’s, regulatory guidelines and cGXP compliance requirements;
• Maintain high standards of quality at the lab through managing and continuously improving the effectiveness of laboratory quality processes and systems.

Manage Team and Resources

• Identify, develop, and retain qualified people to meet the high quality standards. Implement the quality processes. Run an efficient and effective Analytical Laboratory organization through managing the department site budget and resources.

Sustainable Culture of Quality

• Maintain a culture of enhancing quality throughout the entire site operation;
• Risk analyses based quality decision making. Review and provide options to meet business needs without compromising quality and compliance.

Influence Beyond the Site

• Share best practices, challenges and lessons learned within the site across the Quality organization in order to improve the performance of quality globally.

Your experience and qualifications

• University level (Pharmacy/Analytical Chemistry/Microbiology) or HBO+ with several years of experience in a manager position in the pharmaceutical industry;
• Excellent people management and communication skills;
• Experience in the pharmaceutical industry (preferably sterile manufacturing), analysis techniques and cGXP;
• Capability to handle Regulatory authority inspections;
• Knowledge of cGXPs and relevant regulatory guidance;
• Ability to promote continuous process improvement/efficiency;
• Credibility and proactive orientation;
• Problem-solving and result-driven attitude;
• Confident decision-maker.

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Netherlands      Biotechnology and Genetics      On-site      Pre-clinical Research and Development      Teva