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.

What you’ll do:

The Director, Associate General Counsel – Quality will be a pivotal member of the Legal Team with a global scope, focused on providing expert, timely, and practical legal counsel on a broad range of matters related to Global Quality, Regulatory Affairs, and Operations across Lonza’s platforms on issues including compliance with GMP, FDA, EMA, GxP, and other global regulations and guidelines.
Draft, negotiate, and review complex quality agreements and other critical documents related to manufacturing and testing and assess impact on commercial agreements.
Advise senior management on legal strategy regarding product complaints, potential quality issues, investigations, root cause analyses, and risk mitigation.
Support internal and external audits and inspections, including strategizing on responses to regulatory authorities (e.g., FDA Form 483s).
Identify areas of company risk in quality/regulatory areas and drive the development and implementation of mitigation strategies to help ensure quality and regulatory compliance.
Support development and implementation of policies, procedures, and guidelines that impact quality systems.Act as a trusted legal partner to business functions and senior management, balancing risk while actively supporting the achievement of operational and business objectives.

What we’re looking for:

Education: Juris Doctor (J.D.) degree from an accredited law school.
Bar Admission: Member in good standing of a State Bar in the U.S. and eligible to practice in New Jersey as in-house counsel.
Experience: A minimum of 10-12+ years of professional legal experience, with a significant portion focused on quality and regulatory experience in the life sciences, pharmaceutical, or CDMO industry.
Expertise: Advanced and specialized quality and regulatory experience with deep knowledge of FDA, EMA, and global GxP regulations.
Skills: Demonstrated strategic competence in applying legal skills to complex, daily quality and regulatory matters.

What will you get?

The flexibility of a Hybrid work model based in our Morristown, NJ office.
An inclusive, ethical workplace with a focus on making a meaningful difference in the world.
The opportunity to work on cutting-edge life sciences projects that impact patients worldwide
The full-time base annual salary for this position is expected to range between $190,000-$232,000. In addition, below is a comprehensive summary of the benefits package we offer:
Performance-related bonus.
Medical, dental and vision insurance.
401(k) matching plan.
Life insurance, as well as short-term and long-term disability insurance.
Employee assistance programs.
15 PTO days offered/Paid time off (PTO).

Compensation for the role will depend on a number of factors, including the successful candidate’s qualifications, skills, experience, and job-related knowledge.

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.

What you’ll do:

The Director, Associate General Counsel – Quality will be a pivotal member of the Legal Team with a global scope, focused on providing expert, timely, and practical legal counsel on a broad range of matters related to Global Quality, Regulatory Affairs, and Operations across Lonza’s platforms on issues including compliance with GMP, FDA, EMA, GxP, and other global regulations and guidelines.
Draft, negotiate, and review complex quality agreements and other critical documents related to manufacturing and testing and assess impact on commercial agreements.
Advise senior management on legal strategy regarding product complaints, potential quality issues, investigations, root cause analyses, and risk mitigation.
Support internal and external audits and inspections, including strategizing on responses to regulatory authorities (e.g., FDA Form 483s).
Identify areas of company risk in quality/regulatory areas and drive the development and implementation of mitigation strategies to help ensure quality and regulatory compliance.
Support development and implementation of policies, procedures, and guidelines that impact quality systems.Act as a trusted legal partner to business functions and senior management, balancing risk while actively supporting the achievement of operational and business objectives.

What we’re looking for:

Education: Juris Doctor (J.D.) degree from an accredited law school.
Bar Admission: Member in good standing of a State Bar in the U.S. and eligible to practice in New Jersey as in-house counsel.
Experience: A minimum of 10-12+ years of professional legal experience, with a significant portion focused on quality and regulatory experience in the life sciences, pharmaceutical, or CDMO industry.
Expertise: Advanced and specialized quality and regulatory experience with deep knowledge of FDA, EMA, and global GxP regulations.
Skills: Demonstrated strategic competence in applying legal skills to complex, daily quality and regulatory matters.

What will you get?

The flexibility of a Hybrid work model based in our Morristown, NJ office.
An inclusive, ethical workplace with a focus on making a meaningful difference in the world.
The opportunity to work on cutting-edge life sciences projects that impact patients worldwide
The full-time base annual salary for this position is expected to range between $190,000-$232,000. In addition, below is a comprehensive summary of the benefits package we offer:
Performance-related bonus.
Medical, dental and vision insurance.
401(k) matching plan.
Life insurance, as well as short-term and long-term disability insurance.
Employee assistance programs.
15 PTO days offered/Paid time off (PTO).

Compensation for the role will depend on a number of factors, including the successful candidate’s qualifications, skills, experience, and job-related knowledge.

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