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Lonza · 2 days ago

Director, Associate General Counsel

Morristown, NJ

Full-time

Hybrid

Director/Executive

$190K/yr - $221K/yr

10+ years exp

Lonza is a global leader in life sciences operating across five continents, and they are seeking a Director, Associate General Counsel – Quality. This role involves providing legal counsel on global quality and regulatory matters, drafting and reviewing agreements, and advising senior management on legal strategies related to quality issues.

BiotechnologyLife SciencePharmaceutical

Responsibilities

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

Qualification

Juris Doctor (J.D.)Bar AdmissionQualityRegulatory ExperienceFDA KnowledgeEMA KnowledgeGxP RegulationsStrategic Legal Skills

Required

Juris Doctor (J.D.) degree from an accredited law school

Member in good standing of a State Bar in the U.S. and eligible to practice in New Jersey as in-house counsel

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

Advanced and specialized quality and regulatory experience with deep knowledge of FDA, EMA, and global GxP regulations

Demonstrated strategic competence in applying legal skills to complex, daily quality and regulatory matters