Lead, Global Quality Regulatory Intelligence

Lonza•Morristown, NJ

2d•$200,000 - $243,000•Onsite

About The Position

Lonza is a global leader in life sciences operating across five continents. 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. The role will work closely with Regulatory Affairs to align Lonza’s comments, positions and advocacy input across external organizations, trade associations and professional forums. The leader will also define and manage the external GMP communication and engagement landscape, recommending where Lonza should lead, follow, monitor or stay away based on strategic relevance, quality impact, compliance risk and business priorities.

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, with the ability to balance speed, quality, risk and competing priorities.
Demonstrated ability to establish scalable, standardized processes and governance structures that reduce complexity and improve efficiency.
Excellent written and verbal communication skills, with the ability to translate complex regulatory and quality information into clear, actionable business insights.
Strong analytical and problem-solving skills, including the ability to interpret complex data, identify trends and recommend practical solutions.
Demonstrated change agility, organizational skills and ability to operate independently with minimal oversight.
Interest in leveraging innovative technologies, information management tools, analytics and automation to improve regulatory intelligence and reporting.
Strong interpersonal skills and reputation for customer focus, collaboration and effective stakeholder engagement at all levels.
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.

Nice To Haves

People management experience preferred.

Responsibilities

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.
Work 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.
Identify opportunities for Lonza colleagues to participate in external engagement activities, including speaking engagements, planning committees, working groups and industry forums.
Conduct regular review and assessment of incoming intelligence and communicate concerns, trends, gaps, alerts and emerging risks to relevant stakeholders in a timely manner.
Establish, maintain and oversee a sustainable global quality system and end-to-end process for intelligence integration into Quality, including standards, procedures, governance, training, tools and supporting IT systems.
Collaborate with internal subject matter experts, business process owners, site teams and functional leaders to support impact assessments, implementation planning and updates to quality system documents as required.
Drive improvements in training, communication and change management to ensure new or revised regulatory requirements are effectively integrated into quality systems, procedures and business processes.
Provide strategic quality oversight, guidance and consultation to business teams on regulatory requirements, external monitoring outcomes, advocacy priorities and compliance implications.
Design and lead a global community of practice or equivalent governance forum, including global process leads, area process owners and key functional stakeholders.
Define, monitor and report global effectiveness and efficiency metrics to assess process performance, identify compliance signals, communicate trends and drive continuous improvement.
Ensure quality intelligence processes are executed consistently across the organization while enabling timely escalation of concerns, gaps, trends, alerts and emerging risks.
Act as a subject matter expert for inspections and health authority interactions, supporting inspection readiness and drafting responses to observations as needed.