US31 Lonza Tampa LLC
Associate Director Quality Control (Biotech)
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.
Technical proficiency in analytical methodology and global regulatory requirements for drug substances and drug products
Familiarity with domestic and international current good manufacturing practices (cGMPs) and other best practices for pharmaceutical manufacturing operations
Exercising independent judgement within defined procedures and regulations, to provide decisions and guidance regarding compliance issues
Providing leadership within the Quality department
Represent QC on cross-functional project teams and guide professional staff
Oversee the development of QC departmental strategies and objectives
Ensure QC decisions align with Quality System, GMP and regulatory requirements
Manage stability program
Support regulatory PAI and GMP inspections
Track QC metrics and act to improve CRO and CMO method or process performance
Approve procedures with company-wide quality policies and standards
Direct staff and operations within Quality Control groups in accordance with cGMP regulations and the Roche/Genetech's standards
Establish strategic goals and objectives and maintain full strategic responsibility for Quality Control for the site
Monitor and ensure the performance and delivery of results for the Quality Control testing laboratories
Provide leadership and guidance to immediate staff performing Quality Control activities. Support can include sampling, sample management, testing of DS, DP and finished goods (release) as well as raw materials, in-process and environmental monitoring as defined by site requirements
Perform other duties as assigned
Bachelors of Science Degree or higher in Chemistry
Minimum 8 years of pharmaceutical experience
Minimum 3 years of management experience in a pharmaceutical setting.
Strong written and verbal communication skills
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.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.