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 dedicated 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.
The Role is responsible for all Quality related responsibilities for our DPS Business, which includes:
Providing leadership to the Quality Resources within the DPS Business
Defining and completing Quality and regulatory compliance standards
Assuming accountability for all QMS Topic related to the Business (internally and externally)
Fostering a continuous improvement approach to Quality and provide leadership on improving effectiveness of the Quality Systems
Key responsibilities:
Overall responsibility for departmental budget
Leading and developing the Quality Team ensuring, driving workforce planning and ensuring organizational readiness to absorb the growth curve in line with forecast
Developing an effective and cohesive partnership, encouraging close collaboration with internal and external customers
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
Driving all crucial duties to follow Lonza’s Quality Systems as well as Quality Oversight for the DPS Site (such as releasing drug Product, approving all relevant documents, approving sample plans, validation documents, stability documents, and driving risk assessments, specifically compliance gap assessments)
Oversees all external Quality control activities in close collaboration with the suppliers, including but not limited to biochemistry, chemistry, sample management and QC document management.
Developing and maintaining a robust communication and critical issue process to internal and external partners and customers
Driving a lean attitude and establishing mechanism to continuous improvement initiatives are driven in line with plan
Ensuring an appropriate governance for all critical systems, which are co-shared with neighboring technologies / business units
The incumbent is a standing member of the Platform Quality Leadership Team, gives to all Quality DPS LT-Councils, Quality Management Review, New Production Introduction Forums, and global communities of practice.
Key requirements:
University degree or equivalent experience in pharmacy, engineering, chemistry, microbiology or related life sciences field, PhD is helpful
At least 15 years working experience in the pharmaceutical industry and sterile manufacturing with proven capability in quality leadership roles
Strong people leadership skills and a consistent track record in attracting, developing and retaining talent in the organization
Extensive knowledge and expertise of Sterile DP manufacturing processes as well as related quality and management processes and systems,
Ability to drive open quality decision making based on comprehensive data driven risk assessments
Business Knowledge to develop and control budgets, set important critical metrics and ensure follow up
Ability to communicate optimally specifically with customers, regulators and health authorities
Proficient 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 phenomenal privilege, but also a great responsibility. How we achieve our business results is just as meaningful 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 sophisticated 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 relevant difference.