Associate Director, Aseptic Operations

Lonza • Portsmouth, NH

39d • Onsite

About The Position

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 sterili ty. 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

Requirements

• Bachelor’s Degree required in Life Sciences, Pharmacy, Engineering or related field.
• 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.

Nice To Haves

• Six Sigma/Lean or similar process improvement certification is preferred.

Responsibilities

• 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

Benefits

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Director