Lead, Global Quality Regulatory Intelligence

Today, Lonza is a global leader in life sciencesoperating across five continents. While we work in science,there’s no magic formulato how we do it. Our greatest scientific solutionis 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. Andthat’s the kind of work we want to be part of. 

We are looking for a Senior DirectorGlobal Quality Regulatory Intelligence, Advocacy and External Engagement.

Role Purpose: 

The Senior Director Global Quality Intelligence, Advocacy and External Engagement willestablish,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, industrytrends and external policy developments areidentified, assessed,communicated and translated intoappropriate quality system actions ina 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, tradeassociations 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, compliancerisk and business priorities. 

Key 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• Identify,monitor and assess new or revised regulations, draft guidance, health authority expectations, industrytrends and external policy developments todetermine potential relevance to Lonza. 

• Work with Regulatory Affairs and other stakeholders to ensure alignedLonza comments, positions and advocacy inputs across external organizations, trade associations, professionalforums 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, compliancerisk and business priorities. 

• Lead, collaborate and coordinate commenting activities on draft regulations,guidance and policy proposals, ensuring input fromappropriate Quality, Regulatory, Operations, R&D,site and subject matter expert stakeholders. 

• Engage externally through conferences, tradeassociations and professional organizations tomonitor policy changes, influence quality-related regulatoryexpectations and bring relevant insights back to Lonza. 

• Identify opportunities for Lonza colleagues toparticipate in external engagement activities, including speaking engagements, planning committees, workinggroups and industry forums. 

• Conduct regular review and assessment of incoming intelligence and communicate concerns, trends, gaps,alerts and emerging risks to relevant stakeholdersin 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, siteteams and functional leaders to support impact assessments, implementation planning and updates to quality system documents asrequired. 

• 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, advocacypriorities 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, communicatetrends and drive continuous improvement. 

• Ensure quality intelligence processes are executed consistently across the organization while enablingtimely 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. 

Key Stakeholders: 

• Global Quality Leadership and senior functional leaders. 

• Regulatory Affairs and Health Authority-facing teams.

• Business, Site and Operations Leadership. 

• Quality Systems, Compliance and Process Owners. 

• R&D and relevant Subject Matter Experts. 

• Legal, Corporate Affairs and Communications. 

• Health Authorities, Industry Associations and Professional Organizations.

RequiredSkills & Competencies: 

• Experience working with regulatory authorities, healthauthority 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 toestablish 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,identifytrends and recommend practical solutions. 

• Demonstrated change agility, organizationalskills and ability tooperate independently with minimal oversight. 

• Interest inleveraging 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. 

• People management experience preferred. 

Qualification & 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, improvementinitiatives or cross-functional programs in a regulated environment. 

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

• Demonstrated influential leadership skills and experience engaging with senior leaders, internal stakeholders, industryorganizations or health authorities.  

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. 

People come to Lonza for the challenge and creativity of solving complex problems and developingnew ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. 

The full-time base annual salary for this position is expected to range between $200'000 and $243'000 USD. Compensation for the role will depend on a number of factors, including the successful candidate’s qualifications, skills, competencies, experience, and job-related knowledge. Full-time employees receive a comprehensive benefits package including performance-related bonus, medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.