Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
Lonza Walkersville is currently seeking a Head of Quality Assurance (QA) Operations to join our Bioscience team. The individual will be responsible for overseeing and directing all aspects of quality assurance and compliance with applicable regulatory requirements for Media (Liquid and Powder) and LAL products. Develop and direct strategy for assuring compliance to medical device and drug regulations.
Directs staff of QA Media and LAL operations specialists that review and approve device master records, batch records, testing, and aseptic operations. Oversees batch release. Develops and plans strategy and departmental goals, establishes timelines and monitors progress and completion.
Provides oversight of aseptic operations including managing QA on the Floor team to observe aseptic processing, including media fills to meet US and international aseptic processing requirements (FDA Sterile Product Aseptic Processing Guidance and Eudralex, Annex 1,”Sterile Medicinal Drug Products”, ISO 13408 and 21CFR820).
Assesses facility and quality systems’ state of compliance with internal requirements and appropriate regulations, and participates in the development of action plans to correct deficiencies and improve quality processes.
Provides direction for complex deviations and complaint investigations; Managing media deviations, CAPAs and Complaint handling and ensuring that quality related deviations, complaints are escalated, investigated and resolved.
Leads and/or supports regulatory or client audits as Aseptic Media subject matter expert.
Develops and approves cGMP documents including, but not limited to, SOPs, batch records and specifications. Ensures process is efficient.
Bachelor’s degree in life sciences or Engineering required
Substantial GMP (Good Manufacturing Practice) experience in aseptic filling of biologics or equivalent
Substantial management experience in a QA supervisory or management role.
Working knowledge of cell culture starting materials and aseptic drug product filling experience required.
Experience with oversight of aseptic filling and the associated international aseptic drug product processing regulations and medical device regulations.
ASQ Certification (preferred)
GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing; ISO 9001:2015, 13485 and Part 11 compliance knowledge preferred.
Working Knowledge of (LAL) endotoxin testing preferred.
The ability to interface and communicate directly with clients may be required.
Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
Strong collaboration and communication skills required. Ability to multitask and adequate sense of urgency a must.
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.
Internal Number: R22635
At Lonza, we combine technological innovation with world class manufacturing and process excellence. Together, these enable our customers to deliver their discoveries.
We are a preferred global partner to the pharmaceutical, biotech and specialty ingredients markets. Our solutions improve life quality by preventing illness, enabling healthier lifestyles and supporting a safe environment.
We work to prevent illness and promote a healthier world by enabling our customers to deliver innovative medicines that help treat or even cure a wide range of diseases. We also offer a broad range of microbial control solutions, which help to create and maintain a healthy environment.