Associate Director, Aseptic Operations
Location: Portsmouth, NH. Relocation assistance is available for eligible candidates and their families.
The Associate Director of Aseptic Operations is responsible for maintaining superior quality and GMP standards across all operational areas. Key duties include directing deviation management to ensure investigations are completed accurately and on schedule. The role also involves analyzing operational trends to implement holistic, long-term process improvements. Additionally, the incumbent leads the development of training strategies focused on technical skills and aseptic behaviors like gowning and interventions. Finally, they provide aseptic stewardship by contributing to the design and enhancement of facility infrastructure to ensure sterility.
What you will get:
Competitive salary and comprehensive benefits package
Opportunities for career development and advancement
Supportive and collaborative team environment
Access to cutting-edge technology and tools
Commitment to employee well-being and safety
Inclusive workplace culture
Recognition and reward for your contributions
Access to our full list of global benefits: https://www.lonza.com/careers/benefits
What you will do:
Lead the deviation management and aseptic training teams, overseeing staffing, performance, and continuous development to maintain a motivated workforce.
Own end-to-end deviation management to ensure on-time, "right-first-time" closures that align with batch release schedules.
Spearhead quality improvement projects to strengthen the site’s quality culture and proactively reduce the frequency of deviations.
Manage complex root cause analyses and implement effective CAPAs to enhance process performance and verify long-term efficacy.
Collaborate with cross-functional stakeholders and Quality Assurance to drive record completion and meet critical production deadlines.
Oversee all GMP-relevant training for the asset, focusing on reducing "door-to-floor" time and improving training effectiveness.
Partner with site leadership to identify training gaps and develop a comprehensive GMP Training Plan aligned with the latest industry trends
What we are looking for:
Bachelor’s Degree required in Life Sciences, Pharmacy, Engineering or related field.Six Sigma/Lean or similar process improvement certification is preferred.
8+ years of experience in a GMP-regulated industry, preferably in QA, QC, or Manufacturing.
At least 5 years in a quality role and/or role related to aseptic manufacturing.
Strong knowledge of regulatory requirements (FDA, EMA, ICH, WHO) and quality standards (GMP, ISO).
Experience with electronic quality management systems (e.g., TrackWise, Veeva, MasterControl).
Strong experience supporting regulatory inspections (e.g., FDA, MHRA, EMA).
Knowledge of risk management and change control processes.
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.