Senior QA Specialist, QA Operations 80-100% (m/f/d)

Today, 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.

Our Visp Biologics Quality team is looking for an energetic team player with the agility to meet changing priorities and a roll-up-your-sleeves approach to work.  The successful candidate will be someone who drives to meet/exceed KPIs while at the same time enables an atmosphere of continuous improvement.

The Senior QA Specialist (m/f/d) is responsible for supporting the Associate Director, Head of QA Operations BioAtrium  in setting up a strong and innovative team that is perceived as a main contributor to the success of the large scale mammalian operations in our future BioAtrium site.  A great candidate will have strong leadership capabilities, envisioning and driving teamwork, quality culture, and innovation with the goal of becoming a role model within Lonza. We are looking for someone comfortable working in a matrix organization, effective with cross-functional and global projects, someone who can conceptualize where we need to be, how to get there, and drive ideas to completion.  The key stakeholders that the Senior QA Specialist 2 will work closely with the QA Operations team (including QA for QC and QA On The Floor), other QA teams and will interact with the the other Operational teams at BioAtrium like Production, Engineering and Project Management. 

Key responsibilities:

• Comply with, Develop, implement and monitor quality procedures to ensure compliance with GxP standards, corporate policies, Swissmedic, FDA and other regulatory body regulations and guidelines

• Support all QA operations activities concerning SOP landscape, electronic batch records, training,  deviation- / CAPA- and change control management

• Support all audits and inspections

• Identify and implement Lean / OPEX approaches in Quality and foster improvement projects

• Provide KPI reporting and execute action plans to address opportunities for improvement

• Work collaboratively with QA Operations and QA department colleagues

Key requirements:

• Academic degree in a Life Science discipline, Engineering or Quality Management or related field

• Experienced in Quality Assurance

• Audit experience with Swissmedic/FDA/EMA regulations

• Experience with Lean / Operational Excellence / Six Sigma

• GMP compliance expertise

• Ability to interface and communicate directly with customers and regulatory bodies

• Excellent written and verbal communication to include accurate and legible documentation

• Ability to work on call

• Fluent English is required, German language skills - an advantage

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.