Quality Compliance Manager (Lot Disposition) - Cell Therapy

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.

Job Summary:

The Quality Compliance Manager – Lot Disposition, leads a team of QA Lot Disposition Specialists responsible for supporting Lonza’s internal lot release deliverables.  The Quality Compliance Manager ensures staff is meeting objectives and deliverables on time and in full, and plays a key role in customer communications regarding lot disposition.  This position supports the overflow of tasks as needed, assigns resources and priorities, ensures adequate training, coaches and develops staff, and evaluates performance.  Responsible for actively pursuing opportunities for improvement and promoting a strong culture of quality awareness and GMP compliance. This position is responsible for the management of documentation as well as meetings to discuss release deliverables and guiding QA team on release priorities for documentation.

This position requires full time presence at our Portsmouth, NH location. 

Key Responsibilities:

• Ensures objectives are met and expectations align with customer Quality Agreements, Lonza SOPs, and regulatory requirements.

• Partners with internal customers (MSAT, Manufacturing, QC, and QA) and external customers regarding lot disposition deliverables.

• Leads Internal and External Lot Disposition meetings and manages lot release tracking dashboards.

• Manages and tracks Key Performance Indicating Quality Metrics and OTIF for lot disposition.

• Performs Lot Release/Disposition activities and acts as a point of escalation between Lonza and customer. Acts as Senior QA signatory on final lot disposition package for release or reject.

• Identifies and implements improvements to quality processes.

• Provides general direction for department.  Develops team goals, monitors progress and ensures continuous improvement.

• Conducts regularly scheduled 1 on 1 meetings with staff, and conducts regularly scheduled team meetings to review objectives, provide support and feedback, and assistance resolving issues.

• May participate in the hiring process, provides performance feedback, coaches, mentors and supports career development.

• Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.

• Supports Regulatory and Customer Audits as needed.

• Perform other duties as assigned.

Key Requirements:

• Bachelor’s Degree or Equivalent Experience.  A combination of education and years of experience will be considered

• Minimum ten years of Quality Assurance

• Experience managing direct reports and demonstrated ability to mentor and coach employees

• Biotechnology manufacturing background is preferred

• Deep knowledge of GMPs and regulations

• Demonstrated quality decision making skills

• Experience with TrackWise, SAP, Syncade and Microsoft suite of products is preferred.

• Self-motivated person with excellent written and verbal communication skills to all levels, ability to tolerate challenging workloads and changing priorities

• Strong attention to detail is essential

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.