Lead, Global Quality Regulatory Intelligence

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Establish, lead, and continuously enhance Lonza’s global quality process for quality intelligence, advocacy, and external engagement.

• Identify, evaluate, communicate, and convert emerging and updated regulatory requirements, health authority expectations, industry trends, and external policy developments into actionable quality system measures.

• Align Lonza’s feedback, positions, and advocacy contributions with Regulatory Affairs across external organizations, trade associations, and professional forums.

• Define and manage the landscape for external GMP communication and engagement.

• Develop and oversee an integrated strategy for intelligence, advocacy, and external engagement, encompassing standards, governance, tools, intelligence sources, and supporting processes.

• Lead and coordinate commenting activities on draft regulations, guidance, and policy proposals.

• Engage externally through conferences, trade associations, and professional organizations.

• Identify opportunities for colleagues to engage in speaking engagements, planning committees, working groups, and industry forums.

• Review incoming intelligence and convey concerns, trends, gaps, alerts, and emerging risks.

• Establish and supervise a sustainable global quality system and end-to-end intelligence integration process.

• Support impact assessments, implementation planning, and updates to quality system documents.

• Drive training, communication, and change management for the integration of regulatory requirements.

• Provide strategic oversight and consultation on regulatory requirements, monitoring outcomes, advocacy priorities, and compliance implications.

• Design and lead a global community of practice or equivalent governance forum.

• Define, monitor, and report on global effectiveness and efficiency metrics.

• Ensure consistent execution and prompt escalation of quality intelligence concerns.

• Serve as a subject matter expert for inspections and health authority interactions.

⛳️ Requirements

• Experience collaborating with regulatory authorities, health authority publication processes, regulatory intelligence systems, or external service providers.

• Ability to operate effectively within a matrixed global organization, influence without direct authority, and lead diverse cross-functional teams.

• Strong strategic thinking and execution abilities.

• Capability to establish scalable, standardized processes and governance frameworks.

• Excellent written and verbal communication skills.

• Strong analytical and problem-solving capabilities.

• Proven change agility and organizational skills.

• Ability to work independently with minimal supervision.

• Interest in utilizing innovative technologies, information management tools, analytics, and automation.

• Strong interpersonal skills and a focus on customer service.

• People management experience is preferred.

• Several years of experience in the pharmaceutical or biopharmaceutical sector.

• 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 within a regulated environment.

• Strong knowledge of GMP, GDP, GxP regulations, and global quality system expectations.

• Proven influential leadership skills and experience engaging with senior leaders, internal stakeholders, industry organizations, or health authorities.

🏝️ Benefits

• Performance-related bonus.

• Medical and dental coverage.

• 401k plan.

• Life insurance.

• Short-term and long-term disability insurance.

• Employee assistance program.

• Paid time off (PTO).