Associate Director, Head Qc Microbiology 80-100%
vor 4 Stunden
Switzerland, VispToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Head QC Microbiology in Visp, Switzerland.
Key responsibilities:
- Assume overall responsibility for departmental budget
- Provide leadership to a multilayer organization of leaders, technical supervisors and lab technician to ensure organizational readiness to absorb current and future growth business specifically
- Ensuring workforce planning, and ensuring organizational readiness to absorb the growth curve inline with forecast
- Developing an effective and cohesive teamwork, fostering close collaboration with internal and external customers and stakeholders
- Supporting and maintaining robust and reliable product supply to our customers
- Ensuring an inspection readiness state for the site to meet expectations from customers and regulators
- Developing and maintaining a robust communication and escalation process to internal and external stakeholders and customers
- Driving a lean mindset and establishing mechanisms to continuous improvement initiatives to be executed in line with plan
- Ensure main laboratory management systems are in place and developed to the next level
- Develop strategy and plan to ensure Laboraory Capacity and Assets are fit for purpose (short-, mid-, and longterm)
- Main and develop the Laboratory IT Infrastructure inline with global standards
- Orchestrate main Quality Systems and ensure adherence to main regulations (ICH, PIC/S, HMG, CFR, GMP Regulations)
- Establish a continuous improvement mindset
- Oversee and manage departmental performance and quality metrics
- Assume a “Customer First Mindset” and ensure technical and compliance positioning is accurate
Key requirements:
- University Bachelor’s degree in Science with a major in Microbiology and/or Virology with at least 10 years of experience in GxP positions with progressive experience in Biologics/Biopharmaceutical/Pharmaceutical industry or MSc/Ph.D degree with at least 8 years in GxP positions
- Strong pharmaceutical microbiology experience, specifically in dealing with Biologics
- Demonstrated, well developed analytical and problem-solving skills
- Comprehensive knowledge of global GMP regulatory requirements for microbial contamination controls, quality control laboratory operations, environmental and critical utility monitoring and data integrity
- In depth knowledge of requirements of GxP Regulations and guidance of Health Canada, US-FDA, EU in particular data integrity and various compendia (USP, EP, JP)
- Strong drive for results and high capacity to mobilize teams and stakeholders
- Ability to communicate effectively specifically with executive management, peers, teams, as well as customers, regulators and health authorities
- Fluent in German and English
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
- Reference: R58138
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