Sr. QA 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.
Join Lonza AG as a Sr. QA Compliance Specialist-where you'll play a pivotal role in maintaining our world-class compliance standards. This role has been built to support our ambitious growth, ensuring flawless execution of audits and inspections. Located in New Hampshire, USA, you will have the crafted opportunity to drive continuous improvement activities and maintain inspection readiness, making a significant impact on our operations.
The Sr. QA Compliance Specialist is a technical expert on the Compliance team. The Sr. QA Compliance Specialist is an agent for change, drives compliance in CT, models inspection readiness behaviors and leads the appropriate Review Boards across CT. The Sr. QA Compliance Specialist drives continuous improvement activities across CT to ensure the most robust compliance to all appropriate regulations. The Sr. QA Compliance Specialist supports KPI/KQI generation and identifies and responds to trends.
Key Responsibilities:
Develop, improve and monitor Quality System for CT.
Host DRB, CAPA Review Board, Change Control Board.
Review and approve all Quality Records for Compliance.
Support Quality LT by generating KPIs/KQIs during Q Council.
Write and approve Standard Operating Procedures (SOPs).
Work to continuously improve areas impacted by deviations.
Approve appropriate relevant deviations and CAPAs.
Coordinate, support and author audit and inspection responses as needed, with SMEs.
Strive to maintain the highest level of inspection readiness at all times.
Correct weaknesses and mitigate gaps in procedures, processes and policies to enable compliance to Annex 1 and appropriate CFRs.
Manage and Track Key Performance Indicator Quality Metrics.
Support inspections and audits. Drive compliance across CT.
Work effectively and build strong relationships with team members and stakeholders across the organization as well as outside (clients, suppliers, etc.).
Work collaboratively with site leadership to instill an excellent “Quality Culture” by coaching stakeholders on GMP principles in order to maintain a state of “inspection readiness” at all times.
Ability to multitask and prioritize work in dynamic environment.
Excellent organizational, analytical and technical skills are required.
Set personal performance goals and meet departmental objectives.
Excellent written and verbal communication skills.
Mentor and train other quality team members.
Perform other duties as assigned.
Key requirements:
Bachelor's Degree.
5-10 years of experience.
Knowledge of GMP's and regulations preferred (e.g. ICH Q7-Q11, CFR 210, 211, 600-680, 820, etc.).
Superior written and verbal communicator and enabling self to be understood at all levels. Experience with Microsoft Office Tools (e.g. Word, Excel, Outlook, & PowerPoint).
Experience in enterprise systems such as DMS, LIMS, TrackWise, SAP, Syncade, etc.
Self-motivated and results oriented. Able to tolerate challenging workloads and changing priorities, and exercises composure, pays attention to detail.
Works effectively individually and within a team environment.
We are excited to find someone who is as passionate about quality and compliance as we are. If you are ready to compete at an exceptionally high level and contribute to our mission, we would love to hear from you.
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.
