Today, Lonza is a global leader in life sciences operating across three 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.

The Senior Compliance Specialist is a QC role that supports quality and strategic goals of the department. Provides support with audit/inspection requirements to ensure department compliance/readiness and leads audit responses and actions. Acts independently to determine methods and procedures for new assignments. This role includes technical writing of QC quality documentation including deviations, investigations, change controls, CAPA, test methods, reports and SOPs and is a Subject Matter Expert for multiple disciplines. Drives continuous improvement initiatives. Collaborates to prepare project charters, design deliverables and metrics, oversee execution, and compile final project close out. Acts as a backup to the manager and advisor to the team; may oversee the activities of QC personnel to meet schedules and/or overcome barriers. Supports and promotes a culture of quality awareness and compliance.

Must be within (or able to relocate to) commuting range of our Portsmouth NH facility, as regular on-site presence is required for this role

Key Responsibilities

• Manages multiple complex projects and initiatives


• Provides support with audit/inspection requirements to ensure department compliance. Leads GEMBA and owns follow up actions to maintain a state of inspection readiness while driving improvements


• Participates in internal and external audits and inspections. Supports audit and inspection responses, owns associated CAPA and drives actions to completion


• Supports product release activities, including data review


• Manages and delegates action items to responsible parties


• May oversee activities of group members. Able to act as a backup for the manager


• Communicates project milestones. Identifies risks and elevates major barriers to ensure delivery to plan. Promotes team achievements


• Collaborates with department leadership to implement effective corrective and preventative actions


• Supports QC improvement initiatives and lean labs in a variety of project team member roles, including project planning, overseeing project execution, coordinating a multi-disciplinary project team, and project closeout


• Measures and reports appropriate metrics and KPI


• Perform other duties as assigned


• Level of this role is dependent on experience

Key Requirements

• 10+ years of GMP or regulated regulatory industry experience


• 10+ years of Quality Control or Quality Assurance experience


• 10+ years of experience managing quality documents, including deviations and investigations


• Previous experience being involved in audits


• Prioritization and problem solving


• Ability to interpret data and present information in a manner that facilitates understanding


• Direct, plan, and execute tasks/projects; effectively communicate status, needs, forecasts, risks and timelines.


• Excellent communications skills, both written and verbal


• Ability to mentor and lead team members


• Senior team member, able to act as a backup for the manager


• Proficiency in Microsoft Office required. Advanced use of Enterprise GMP Quality Systems such as: TrackWise, DMS, LIMS, electronic notebook

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.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.