Senior Supplier Quality Professional

United States, Portsmouth (New Hampshire)

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 Senior Supplier Quality Professional is an experienced Quality Auditor with experience in managing and executing supplier audits in the pharmaceutical, biotech, or medical device industry. In this role, you will act as a Single Point of Contact for assigned suppliers on behalf of the regional head. The Sr. Supplier Quality Professional will ensure the uninterrupted supply of materials and services to Lonza by assessing the quality of the Suppliers and their ability to meet defied requirements utilizing tools such as Quality Risk Management (QRM), supplier assessment/audit, change management and compliant/deviation trend management.

Key Responsibilities:

  • Perform Supplier Quality assessments/ audits of Suppliers to annual plan and follow up on agreed upon CAPAs.  
  • Assure issues are timely classified, communicated to the supplier and to Lonza Sites.
  • Ensure that Change requests, either from the assigned Supplier or from Lonza are managed according to the Quality Agreement and Lonza SOPs from receipt, through to the implementation and closure. 
  • Participate in the Reporting on QA Supplier performance; this is to include Risk Assessment ranking and managing of defined KPI’s. Monitor Key Performance Indicators and ensure work is performed in a consistent manner against harmonized expectations.
  • Initiate corrective actions when necessary and perform follow-up on resulting measures. Support Lonza QMS and SOPs for Global Supplier Quality as assigned.
  • Responsible for mitigating quality trends and driving continuous improvement for processes and product quality performance for assigned suppliers. Support Regional Head to find solutions to complex manufacturing, quality and negotiation problems.
  • Provide training and mentorship to less experienced members of the team

Key Requirements:

  • Substantial knowledge of GMP regulations and quality regulatory requirements in a cGMP manufacturing environment (FDA, EMA and other cGMP regulations and guidelines)
  • Must be able to effectively write reports and assess corrective action plans without supervision.
  • Must be detail oriented, exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to maintain customer confidential at all times
  • Excellent interpersonal, verbal and written communication skills
  • Excellent problem solving, risk analysis and negotiation skills
  • Ability to travel to perform vendor audits
  • ASQ and/or RAB auditor accreditation is highly desirable
  • Bachelor's degree or equivalent work experience in a scientific or technical discipline
  • Travel will be required and could be in upwards of 50%
  • Bilingual is a bonus, Spanish/English preferred.

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: R20553