Senior QA Director, Quality Systems & Compliance

Lonza Group; Walkersville (MD); On-site; USD 168,000 - 196,000; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance

short-term and long-term disability

Employee assistance programs

Paid time off (PTO)

Job summary

Lonza Group in Walkersville, MD is seeking an Associate Director, Quality Assurance to lead the site Quality Systems organization and ensure compliance across manufacturing operations.

You will manage a team of about 5–10 professionals, oversee Change Control, Deviations, Investigations, CAPA, and Customer Complaints, and partner with Quality, Manufacturing, Regulatory Affairs and site leadership to maintain inspection-ready systems.

Qualifications

• Bachelor's degree in Life Sciences or related field; advanced degree preferred.
• 10+ years of QA experience in regulated manufacturing environments.
• 5+ years of leadership in Quality Systems.
• Experience with Change Control, Deviations, Investigations, CAPA, Customer Complaints, Risk Management and Compliance programs.
• Strong understanding of FDA, EU GMP, ISO 13485 and applicable cGxP regulations.
• Experience driving quality improvements and supporting regulatory inspections.

Responsibilities

• Lead and oversee the site Quality Systems organization and its QMS processes.
• Lead a team of approximately 5-10 quality professionals.
• Provide strategic and operational oversight for Change Control, Deviations, Investigations, CAPA, Customer Complaints, Effectiveness Checks, Document Control, Label Control and related processes.
• Ensure Quality System records are initiated, investigated, reviewed, and closed timely with risk assessments and root cause analysis.
• Serve as process owner for key Quality Systems programs and drive standardization and continuous improvement across the site.
• Monitor quality metrics, identify risks, and communicate findings to Quality and Site Leadership.
• Support internal audits, customer audits and regulatory inspections; participate in responses and corrective actions.

Skills

Quality Systems

Leadership

Change Control

Deviations

Investigations

CAPA

Customer Complaints

Risk Management

Regulatory Compliance

FDA & GMP Knowledge

TrackWise

MODA

SAP

Communication

Cross-functional Collaboration

Education

Bachelor’s degree in Life Sciences

Tools

TrackWise

MODA

SAP

Job description

Lonza Group in Walkersville, MD is seeking an Associate Director, Quality Assurance to lead the site Quality Systems organization and ensure compliance across manufacturing operations.

You will manage a team of about 5–10 professionals, oversee Change Control, Deviations, Investigations, CAPA, and Customer Complaints, and partner with Quality, Manufacturing, Regulatory Affairs and site leadership to maintain inspection-ready systems.