Senior Quality Compliance Specialist (Biotech)

 

Today, Lonza is a global leader in life sciences operating across five 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.

At Lonza, we are on a journey of daring growth and innovation. We are seeking a dedicated and hardworking Senior Quality Compliance Specialist to join our team in New Hampshire, USA! This is an outstanding opportunity to become a part of an exceptional organization that values flawless execution and a collaborative spirit!

As a Senior Quality Compliance Specialist, you will be the Subject Matter Expert for document review throughout the site. You will ensure the highest standard of quality and regulatory compliance by meticulously reviewing and approving both electronic and paper documents. Your expertise will not only uphold our outstanding quality standards but also serve as a role model for others in the team.

Key responsibilities:

• Apply an identified standard to independently review and approve initial versions and revised documents such as SOPs, Master Batch Records, Work Instructions, Test Methods, Specifications, Forms, Checklists, and Scanned Documents within the Document Management System (DMS).
• Review and approve electronic/paper Validation and Qualification documents, including Protocols and Summary Reports for CIP, SIP Equipment/Instrumentation, Validation Maintenance, Computer Systems, and Stability.
• Approve non-DMS documents, such as QA Monthly Preventative Maintenance, Engineering Preventative Maintenance documents, CMMS Forms, Instrument Data Sheets, and Facility Forms.
• Evaluate document changes to determine their impact on regulatory and operational compliance.
• Provide detailed document review observations and suggested edits/comments.
• Strictly follow Lonza's documentation review procedures ensuring changes are justified and accurately reflected.
• Partner with internal customers as the Quality Subject Matter Expert for Documentation Changes & Review.
• Support departmental projects, including PQR reports and interim data analysis.
• Attend meetings well-prepared to discuss projects/changes and identify quality requirements, defining the path forward for Documentation revision. Consult with QA Management on broader impacts to the site.
• Lead departmental projects by defining project plans, scope, and deliverables.

Key requirements:

• Bachelor's Degree
• 5-10 years of experience
• Preferred knowledge of GMP regulations (e.g., ICH Q7-Q11, CFR 210, 211, 600-680, 820, etc.)
• Outstanding written and verbal communication skills, proficient in Microsoft Office Tools (e.g., Word, Excel, Outlook, PowerPoint)
• Experience with enterprise systems such as DMS, LIMS, TrackWise, SAP, Syncade
• Driven and goal-oriented, with the ability to manage demanding workloads and adapt to changing priorities, while paying attention to detail.
• Effective both independently and in a team environment

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.