Lead, Global Quality Regulatory Intelligence

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world.

And that’s the kind of work we want to be part of. We are looking for a Senior Director Global Quality Regulatory Intelligence, Advocacy and External Engagement.

Role

Purpose:

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.

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.

• 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• Identify, monitor and assess new or revised regulations, draft guidance, health authority expectations, industry trends and external policy developments to determine potential relevance to Lonza.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.

Quality Compliance and QMS Responsibilities 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…