Quality Control Project Manager I
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 QC Project Manager is assigned as the primary liaison to an external customer(s) for all QC related items including temporary and permanent change controls, deviations, standalone investigations, CAPAs, Product Quality Reviews, and GMP Records. Responsible to facilitate discussions between customers and internal groups such as QC, PV, MSAT, Manufacturing, Engineering and QA. For these quality-related items, the Project Manager coordinates the process for notifying the customer and assuring the customer’s feedback and comments are addressed, verifies that the quality records are complete; that there is sound justification/scientific rationale; supports root cause analysis and identification of corrective and preventive action. Where applicable, the Program Manager assists in obtaining customer approval. The QC Project Manager leads Analytical Project Team meetings –establishes agendas, publishes meeting minutes and tracks action items; participates in Internal and Joint Project Team (IPT/JPT) meetings as the QC representative and tracks and publishes monthly and quarterly quality KPIs.
Must be within (or able to relocate to) commuting range of our Portsmouth NH facility, as regular on-site presence is required
- Manages multiple complex customer project teams as the Quality Control representative.
- Delegates and manages action items to appropriate responsible parties.
- Interprets analytical reports and effectively communicates content to external and internal stakeholders. Measures appropriate metrics and report them to management.
- Coordinates efforts between manufacturing, customer and Quality Control to assure that testing is prioritized, completed on time and communicated in an effective and timely manner.
- Creates, revises and reviews Good Manufacturing Practices (GMP) documentation, which includes specifications, protocols and reports.
- Review and approve various product specific documents such as batch records, sample plans, sample maps, etc.
- Collaborate and prioritize with QC leaders, other departments, and/or customers to create an achievable work schedule and to ensure agreed upon timelines are met.
- Interacts with internal and external customer as part of Joint and Internal project Teams serving as the QC Subject Matter Expert.
- Initiates and drives quality records, for example change controls, investigations, deviations, CAPAs, etc.
- Works independently to drive tasks to completion.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations.
- Perform other duties as assigned.
- Level of this position is dependent on experience.
- Bachelor's Degree required. Area of study in Microbiology, Biochemistry or Related Science Fields.
- Minimum 5 years of experience within GMP/GLP industry with working experience in a QC laboratory or QC setting
- Preferred previous project management experience
- Working experience using GMP Quality Systems (ex. TrackWise, LIMS)
- Excellent communication skills with the ability to collaborate across multiple teams and projects
- Strong computer skills
- Ability to exercise judgment within defined practices and policies in selecting methods and techniques for obtaining solutions and/or taking appropriate actions
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.