Senior QA Leader for Quality Systems & Compliance

Lonza Biologics, Inc.; Walkersville (MD); On-site; Confidential; Full time

Benefits offered by this job

Performance bonus

Medical, dental and vision insurance

401(k) matching

Life and disability insurance

Employee assistance programs

Paid time off

Job summary

Lonza Biologics, Inc. seeks an Associate Director of Quality Assurance to lead the site Quality Systems organization in Walkersville, MD. You will own change controls, deviations, investigations, CAPAs and customer complaints, ensuring compliance and continuous improvement.

You will build and coach a high‑performing team, interface with manufacturing, regulatory affairs and site leadership, and support audits and regulatory inspections with effective responses.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Chemistry, Microbiology, or related discipline; advanced degree preferred.
• 10+ years of Quality Assurance experience in regulated environments.
• 5+ years in leadership managing Quality Systems and teams.
• Strong knowledge of Quality Management Systems (QMS) and cGMP.
• Experience with regulatory inspections and responses.

Responsibilities

• Lead a team of 5–10 quality professionals across Quality Systems and compliance.
• Oversee Change Control, Deviations, Investigations, CAPA, Customer Complaints and related processes.
• Ensure timely initiation, investigation, review and closure of Quality System records with risk assessments and root cause analyses.
• Serve as process owner for key Quality Systems programs and drive improvement across the site.
• Monitor quality metrics and escalate risks to site leadership as needed.
• Coordinate governance for critical quality events and regulatory responses.
• Partner with site leaders to implement corrective actions and strengthen the quality system.
• Provide coaching to ensure thorough investigations and sustainable remediation actions.
• Support internal and regulatory audits and inspections with robust responses.
• Foster a culture of quality, accountability and continuous improvement.

Skills

Leadership

Quality systems

Regulatory knowledge

Communication

Stakeholder management

Change control

Risk management

Education

Bachelor's degree in Life Sciences/Engineering/related

Advanced degree preferred

Tools

TrackWise

MODA

SAP

Job description

Lonza Biologics, Inc. seeks an Associate Director of Quality Assurance to lead the site Quality Systems organization in Walkersville, MD. You will own change controls, deviations, investigations, CAPAs and customer complaints, ensuring compliance and continuous improvement.

You will build and coach a high‑performing team, interface with manufacturing, regulatory affairs and site leadership, and support audits and regulatory inspections with effective responses.