US02 Lonza Biologics Inc.
QA Project Manager, Inspection and Audit Management (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.
The QA Project Manager, Inspection and Audit Management is responsible for
supporting the implementation and execution of the Annual Quality and
Internal Audit plans; PQR SME support as required; supporting
internal/global, customer, and regulatory inspection programs.
Works closely with site leadership and customers to implement effective
corrective and preventive actions in response to deficiencies. Develop
appropriate Observation Responses that are Right First Time
Must be within (or able to relocate to) commuting range of our Portsmouth NH facility, as regular on-site presence is required for this role
Key Responsibilities:
Internal Audits:
Act as a Technical Writer for all Observations, CAPA, Audit Reports that result from an internal audit
Escalate issues to supervisor when needed.
Support opening and closing meetings and communicate concerns to the departments in scope.
Participate in internal audits and walkthroughs
Author the Annual Quality Plan (AQP)Annual Internal Audit Report and Annual Internal Audit Plan, as assigned.
Lead projects; define project plan, scope, and deliverables, as assigned.
Develop training materials for department and site personnel, as assigned.
Mentor and train other QA Specialists in all aspects of the role.
Customer audits, regulatory inspections, and Lonza Global compliance audits:
Act as Back Room staff.
Liaise with the site to fill front room requests from hosts. Disseminate information effectively or support in the front room if appropriate.
Coach SMEs on the appropriate interaction with the front room. Aid in the success of audits and inspections by appropriately triaging information.
Lead Observation and CAPA Meetings
Write Observations for submission and CAPA action plans with site SMEs Overall development of documentation, metrics and trending for audit related information
Key Requirements:
High School Diploma. Bachelor's preferred, area of study: Scientific related field
5 or more years in GMP
Direct exposure to Regulatory Inspections and Customer Audits
Advanced knowledge of cGMP's and regulations
Self-motivated and results oriented, with superior written and verbal communicator at all levels, able to tolerate
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.