Global Quality & Regulatory Intelligence Lead

Lonza; Morristown, Northern (NJ, KY); Hybrid; Confidential; Full time

Benefits offered by this job

Performance bonus

Healthcare coverage

401k

Life insurance

PTO

Job summary

Lonza in Morristown, NJ, seeks a Senior Director Global Quality Intelligence, Advocacy and External Engagement to establish and lead Lonza’s global quality intelligence process. You will identify regulatory developments, coordinate strategic advocacy, and align comments across health authorities and industry forums.

This role partners with Regulatory Affairs and senior leaders to shape external engagement and quality actions.

Qualifications

• Several years of experience in the pharmaceutical or biopharmaceutical industry across Quality, Regulatory Affairs, Operations, R&D or related regulated functions.
• Direct experience with regulatory intelligence, external monitoring, impact assessment, benchmarking, policy, advocacy or engagement with health authorities and trade associations.
• Demonstrated experience leading global or enterprise-wide processes, governance forums or cross-functional programs in a regulated environment.
• Strong knowledge of GMP, GDP, GxP regulations and global quality system expectations.
• Influential leadership skills and experience engaging with senior leaders and internal stakeholders.

Responsibilities

• Develop and manage Lonza’s integrated intelligence, advocacy and external engagement strategy, including standards, governance, tools and processes.
• Identify and assess new or revised regulations, health authority expectations, industry trends and external policy developments.
• Ensure aligned Lonza comments, positions and advocacy inputs across external organizations and trade associations.
• Define and manage Lonza’s communication and engagement landscape based on strategic relevance and risk.
• Lead, coordinate commenting on draft regulations and policy proposals with cross-functional stakeholders.
• Engage externally through conferences and professional organizations to monitor policy changes and insights.

Skills

Strategic leadership

Regulatory intelligence

Stakeholder engagement

GxP compliance

Communication skills

Job description

Lonza in Morristown, NJ, seeks a Senior Director Global Quality Intelligence, Advocacy and External Engagement to establish and lead Lonza’s global quality intelligence process. You will identify regulatory developments, coordinate strategic advocacy, and align comments across health authorities and industry forums.

This role partners with Regulatory Affairs and senior leaders to shape external engagement and quality actions.