Lead, Global Quality Regulatory Intelligence

Lonza; United States; Remote; Confidential; Full time

Benefits offered by this job

Bonus

Medical Insurance

Dental Insurance

401k

Life Insurance

Disability Insurance

Employee Assistance Program

Paid Time Off

Job summary

Lonza in the United States is seeking a Senior Director Global Quality Regulatory Intelligence, Advocacy and External Engagement to lead the global quality intelligence and external engagement program. You will translate regulatory developments into quality actions and align advocacy inputs across health authorities, trade groups and forums.

The role drives strategy, governance, and collaboration with Regulatory Affairs and senior stakeholders to monitor policy changes and ensure timely,

Qualifications

• Several years of experience in pharma/biopharma, across Quality, Regulatory, Operations, R&D or related regulated functions.
• Direct experience with regulatory intelligence, external monitoring, impact assessment and policy engagement.
• Demonstrated leadership in global or enterprise-wide governance and cross-functional programs.

Responsibilities

• Develop and manage Lonza's integrated intelligence, advocacy and external engagement strategy.
• Identify and assess new or revised regulations and industry trends for relevance to Lonza.
• Coordinate comments and advocacy inputs across external organizations and forums.
• Define and manage Lonza's external engagement landscape and monitoring of policy changes.
• Lead commenting on draft regulations and ensure input from Quality, Regulatory, Ops, R&D and SMEs.
• Engage externally through conferences and associations to monitor policy changes.
• Identify opportunities for Lonza colleagues to participate in external activities.
• Review incoming intelligence and communicate risks to stakeholders.

Skills

Regulatory intelligence

Stakeholder engagement

Strategic thinking

Global quality systems

Cross-functional leadership

Regulatory affairs collaboration

Analytical & problem-solving

Education

Pharmaceutical/biopharmaceutical experience

Tools

Regulatory intelligence systems

Job description

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.

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, 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 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.

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.

Required Skills & Competencies:

• 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.

• 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, 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.

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 developing new 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.