Associate Director, QA Ops
Lonza•Portsmouth, NH
•Onsite
About The Position
We are seeking a strategic and experienced Associate Director, QA Operations, to provide quality oversight of cGMP manufacturing activities within our cell therapy operations. This role is a key member of the site Quality Leadership Team, responsible for ensuring compliance across sterile manufacturing environments while driving continuous improvement and fostering a strong culture of quality. The ideal candidate brings deep technical expertise, leadership experience, and the ability to partner cross-functionally to support operational excellence and regulatory compliance.
Requirements
- Bachelor’s degree in science, Engineering, or a related field; advanced degree (MS/PhD) preferred
- 8–12 years of experience in quality assurance within a biotechnology, pharmaceutical, or regulated manufacturing environment
- Demonstrated leadership experience managing and developing teams within a GMP environment
- Strong knowledge of cGMP regulations, sterile manufacturing, and cell therapy or biologics operations
- Proven experience leading or supporting deviations, CAPA, change control, and quality investigations
- Experience with enterprise quality systems (e.g., TrackWise, LIMS, ELN, SAP or similar platforms)
- Strong analytical and decision-making skills, with the ability to interpret data and drive risk-based quality decisions
- Excellent communication and leadership skills, with the ability to influence stakeholders and operate effectively in a cross-functional, matrixed environment
Responsibilities
- Provide end-to-end quality oversight of cGMP manufacturing operations, including sterile processing across Grades A/B/C/D environments
- Ensure alignment with global quality standards, regulatory requirements, and customer Quality Agreements across all QA activities
- Partner with cross-functional teams (Manufacturing, MSAT, Engineering, QC, Validation, and Supply Chain) to resolve complex quality issues, including deviations, CAPA, and change controls
- Lead and participate in key quality governance forums, including Change Control, Deviations Review Board, CAPA Board, and Site Quality Council
- Manage, develop, and mentor QA staff, including resource planning, performance management, and talent development
- Drive continuous improvement initiatives to enhance quality systems, operational efficiency, and overall GMP compliance
- Support regulatory inspections and customer audits, ensuring audit readiness and effective response to findings
Benefits
- Performance-related bonus
- Medical, dental and vision insurance
- 401(k) matching plan
- Life insurance, as well as short-term and long-term disability insurance
- Employee assistance programs
- Paid time off (PTO)
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What This Job Offers
Job Type
Full-time
Career Level
Manager
