Job Description

United States, Portsmouth (New Hampshire)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there\xe2\x80\x99s 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\xe2\x80\x99s the kind of work we want to be part of.

The Quality Assurance Manager - Operations Manager leads a team of QA Compliance Specialists and QA Project Managers responsible for supporting Lonza\xe2\x80\x99s internal and external customers. The QA 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.

Responsibilities

• Provides general direction and support and acts as a point of escalation for 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.
• Manages and tracks Key Performance Indicating Quality Metrics including monthly/quarterly deviation trending reports for senior site management.
• Performs Lot Release/Disposition activities.
• 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.
• Supports Regulatory and Customer Audits as needed.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations
• Perform other duties as assigned

Key Requirements:

• Bachelor\xe2\x80\x99s degree
• 5-10 years of experience
• 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\xe2\x80\x99s 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: R55855
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