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Form of work
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.
The Quality Assurance Operations Manager provides Management oversight of Quality Assurance Department to key disciplines in a regulated or complex environment related to Operations, Batch Review, Customer support, Validation/Qualification, Systems or Training and other key aspects in support of Manufacturing and Packaging operations.
Key Accountabilities:
Provides Quality leadership to ensure that manufacturing and packaging operations are conducted in compliance with Good Manufacturing Practices
Develop, implement and maintain continuous improvement initiatives
Disseminates Quality best practice throughout the organization through training, presentations, etc..
Preparation, execution and follow up for customer audits and regulatory inspections
Executes Internal audit program activities as necessary
Participates in Deviation investigations, root cause analysis, impact assessments, and corrective or preventive actions
Manages review of Master and Executed batch records and related documentation.
Ensures Quality Team Leads, and team are actively engaging on the GMP manufacturing and packaging floor providing support and guidance to personnel, performing Quality activities and executing documentation review concurrent with GMP Operations.
Participates in customer calls to provide program status updates, resolve issues, and maintain effective Quality representation.
Interacts with customer audits and regulatory inspections and provides support and guidance as Operations area SME.
Development, implementation and management of all quality systems and activities
Establish, maintain, trend and report Quality KPI and metrics
Participate in Management Review/Quality Review Board
Participate in Risk Analysis/Risk Management activities
Participate in Technology Transfer activities
Provides training and coaching to other employees to improve their performance and capabilities
Develops and manages a team of QA Operations personnel
Key Requirements:
Bachelor's degree required. Preferably in Science or related field.
8 years of management and leadership experience particularly in Pharma.
Pharmaceutical cGMP experience.
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.
