Hiring: Lead, Global Quality Regulatory Intelligence Company: Lonza Location: Morristown, NJ Job Posted Time: 2026-09-16 15:48:05 Employment Type: Full-time Target Skills & Keywords : Change Management, R About the job Experience: •Several years of experience in the pharmaceutical or biopharmaceutical industry, preferably 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, improvement initiatives or cross-functional programs in a regulated environment. •Strong knowledge of GMP, GDP, GxP regulations and global quality system expectations. •Demonstrated influential leadership skills and experience engaging with senior leaders, internal stakeholders, industry organizations or health authorities. Required Skills: •The Senior Director Global Quality Intelligence, Advocacy and External Engagement will establish , lead and continuously improve Lonza’s global quality process for quality intelligence, advocacy and external engagement. •This role is accountable for ensuring that emerging and revised regulatory requirements, health authority expectations, industry trends and external policy developments are identified , assessed, communicated and translated into appropriate quality system actions in a timely , consistent and compliant manner. •Develop and manage Lonza’s integrated intelligence, advocacy and external engagement strategy, including standards, governance, tools, sources of intelligence and supporting processes. •Identify , monitor and assess new or revised regulations, draft guidance, health authority expectations, industry trends and external policy developments to determine potential relevance to Lonza. •Interface directly with Regulatory Affairs and other stakeholders to ensure aligned Lonza comments, positions and advocacy inputs across external organizations, trade associations, professional forums and direct commenting opportunities. •Define and manage Lonza’s communication and engagement landscape, including recommendations on where Lonza should lead, follow, monitor or stay away based on strategic relevance, quality impact, compliance risk and business priorities. •Lead, collaborate and coordinate commenting activities on draft regulations, guidance and policy proposals, ensuring input from appropriate Quality , Regulatory, Operations, R&D, site and subject matter expert stakeholders. •Engage externally through conferences, trade associations and professional organizations to monitor policy changes, influence quality-related regulatory expectations and bring relevant insights back to Lonza. Compensation: •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!