Quality Assurance Project Lead

United States, Houston (Texas)

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.

Houston's Lonza Cell and Gene Therapy Facility is the largest in the world and our facility is growing. We are looking for professionals to grow with us and we have this exciting opportunity in the Quality Assurance (QA) group. The QA Project Lead is assigned as the primary liaison to an external customer(s) for all quality-related items including temporary and permanent change controls, deviations, standalone investigations, CAPAs, Product Quality Reviews and Quality Agreements and facilitates discussions between customers and internal groups such as MSAT, Manufacturing, Engineering and QC.  For these quality-related items, the incumbent manages 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, that root cause analysis and corrective and preventive action is appropriate and, where applicable, that customer approval is received.   The QA Project Lead leads Joint Quality Team meetings –establishes agendas, publishes meeting minutes and tracks action items; participates in Internal and Joint Project Team (IPT/JPT) meetings as the QA representative and tracks and publishes monthly and quarterly quality KPIs.  

Key responsibilities:

  • Participates in departmental Functional Leadership Team meetings and provides input on departmental strategic decisions.
  • Oversee projects from concept to completion; create and manage project plan, work cross functionally to ensure right first time and provide adequate training to impacted areas
  • Support the Deviation, Investigation, change control  and CAPA processes specific to their assigned customers.
  • Interact with internal and external customer as part of Joint and Internal project Teams serving as the Quality Subject Matter Expert for any customer related quality issues.
  • Track and present customer metrics.
  • Review various product specific documents such as Quality Agreements, Product Quality Reviews etc.
  • Support customer audits.

Key requirements:

  • Bachelor’s Degree Preferred area of study:  Scientific related field
  • Advanced years in GMP environment. Industry experience in Quality Assurance. Biotechnology manufacturing background is preferred
  • Knowledge of cGMPs and regulations
  • Project Management Experience: Presentation, Customer Liaison, Meeting facilitation
  • Demonstrates flexibility to adapt to changing business priorities. 
  • Ability to work inter-departmentally and with customers.
  • High level of suite specific operations and technical skills.
  • Demonstrates role model behaviors for operating in a GMP manner.
  • Demonstrate ability for effective Planning, Organizing and Controlling competency
  • Demonstrate sound decision making, considering broad scope of factors
  • Able to manage multiple priorities and achieve results.
  • Good ability to complete assignments under tight timelines, and work under pressure.
  • Experience with Trackwise, SAP, Document management system preferred
  • Self-starter, solid written and verbal communication, good attention to detail, works effectively individually and with teams, positive attitude, customer focused,
  • Practices safety awareness at all times

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.

Reference: R33900
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