Lead, Global Quality Regulatory Intelligence

🔥 14 hours ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $200k - $243k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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Lonza

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1897

🧬 Biotechnology

💊 Pharmaceuticals

🏭 Manufacturing

💰 $444.8M Post-IPO Debt - Lonza on 2023-11

Biotechnology • Pharmaceuticals • Manufacturing

Lonza is a Swiss-based, global contract development and manufacturing organization (CDMO) and life sciences company. It provides integrated end-to-end offerings across biologics and small-molecule drug development and manufacturing — including cell line development, process and analytical development, formulation and primary packaging, drug substance and drug product manufacturing, and regulatory/CMC support. Lonza's capabilities span advanced synthesis and APIs (including HPAPIs), bioconjugation and ADCs, specialized modalities such as cell & gene therapies, mRNA/LNP, microbial processes, and capsule and health-ingredient products. Founded in Switzerland in 1897, Lonza describes itself as a pioneer and world leader in the CDMO industry and operates with ~20,000 colleagues across five continents to support pharmaceutical and biotech customers.

📋 Description

• Establish, lead and continuously improve Lonza’s global quality process for quality intelligence, advocacy and external engagement • Identify, assess, communicate and translate emerging and revised regulatory requirements, health authority expectations, industry trends and external policy developments into quality system actions • Align Lonza’s comments, positions and advocacy input with Regulatory Affairs across external organizations, trade associations and professional forums • Define and manage the external GMP communication and engagement landscape • Develop and manage integrated intelligence, advocacy and external engagement strategy, including 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 participate in speaking engagements, planning committees, working groups and industry forums • Review incoming intelligence and communicate concerns, trends, gaps, alerts and emerging risks • Establish and oversee a sustainable global quality system and end-to-end intelligence integration process • Support impact assessments, implementation planning and quality system document updates • Drive training, communication and change management for regulatory requirement integration • Provide strategic quality 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 global effectiveness and efficiency metrics • Ensure consistent execution and timely escalation of quality intelligence concerns • Act as a subject matter expert for inspections and health authority interactions

🎯 Requirements

• Experience working with regulatory authorities, health authority publication processes, regulatory intelligence systems or external service providers • Ability to work effectively in a matrixed global organization, influence without direct authority and lead diverse cross-functional teams • Strong strategic thinking and execution capability • Ability to establish scalable, standardized processes and governance structures • Excellent written and verbal communication skills • Strong analytical and problem-solving skills • Demonstrated change agility and organizational skills • Ability to operate independently with minimal oversight • Interest in leveraging innovative technologies, information management tools, analytics and automation • Strong interpersonal skills and customer focus • People management experience preferred • Several years of experience in the pharmaceutical or biopharmaceutical industry • 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

🏖️ 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)