Senior Manager, Quality Operations (Cell Therapy) (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 Sr. Manager, Quality Operations leads a team of QA OTF Specialists and QA Project Managers responsible for supporting Lonza's internal and external customers. The manager ensures staff is meeting objectives and deliverables on time and in full, and plays a key role within the site leadership team. 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.

Key responsibilities:

• Accountable for scheduling and delivering quality on the floor support to manufacturing and logistics operations and ensuring batch records are reviewed by quality in a timely manner.
• Provides general direction and support and acts as a point of escalation for manufacturing and QA staff and customers.
• Ensures objectives are met and expectations align with customer Quality Agreements, Lonza SOPs, and regulatory requirements.
• Partners with internal customers (MSAT, Manufacturing, Engineering, QC, Validation, and Supply Chain) to assess and resolve higher risk issues with Change Controls, Deviations, CAPA, and Investigations.
• Attends and/or co-chairs Change Control Committee, Deviations Review Board and CAPA Board meetings.
• Attends Site Quality Council and Lot Disposition meetings.
• 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.
• Acquires and develops talent, provides performance feedback, coaches, mentors and supports career development.
• Supports Regulatory and Customer Audits as needed. Perform other duties as assigned .

Key requirements:

• Detailed knowledge and understanding of regulatory requirements, biopharmaceutical sterile drug product manufacturing and quality assurance operations.
• Strong knowledge in the application of cGMP requirements, biomanufacturing processes, and purpose and function of manufacturing equipment and processes.
• Understanding of facility design requirements and GMP to show the design as delivered is fit for use. Understanding of validation/qualification principles, industry practices, and standards with ability to apply these to GMP operations.
• Understanding of the principles of biologics manufacturing.
• Demonstrated ability to lead teams of diverse skill sets, make sound decisions regarding evaluation of validation programs, and abilities to influence at various levels in a cross-functional organization.
• Able to manage large, complex projects to successful conclusion.

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.