Quality Assurance Leader: QMS & Compliance

Lonza; Walkersville (MD); On-site; Confidential; Full time

Benefits offered by this job

Bonus

Health insurance

401(k)

Life Insurance

Disability

EAP

PTO

Job summary

Lonza in Walkersville, MD is hiring an Associate Director, Quality Assurance to lead the site Quality Systems and drive compliance across manufacturing operations. You will oversee change control, deviations, investigations, CAPA, complaints, document and label controls, and quality metrics while partnering with Quality, Manufacturing, Regulatory Affairs and site leadership.

The role requires a strong background in FDA, EU GMP, ISO 13485 and cGMP/cGxP regulations, plus experience guiding audits

Qualifications

• 10+ years of Quality Assurance experience within regulated manufacturing environments.
• Strong leadership experience managing Quality Systems functions and high-performing teams.
• Demonstrated expertise with Quality Management Systems and related programs.

Responsibilities

• Lead and develop a team of quality professionals responsible for Quality Systems processes and compliance activities.
• Provide strategic and operational oversight for Change Control, Deviations, Investigations, CAPA, Customer Complaints, Effectiveness Checks, Document Control, Label Control, and related quality system processes.
• Ensure Quality System records are initiated, investigated, reviewed, and closed in a timely manner with appropriate risk assessments, root cause determination, and documented evidence.
• Serve as process owner for key Quality Systems programs and drive standardization, compliance, and continuous improvement across the site.
• Monitor and trend quality metrics, identify emerging risks or compliance concerns, and communicate findings to Quality and Site Leadership.
• Establish governance and escalation processes for critical quality events, ensuring appropriate management visibility and timely resolution.
• Partner with site functional leaders to assess process performance, implement corrective actions, and strengthen overall quality system effectiveness.
• Provide coaching, mentoring, and technical guidance to support thorough investigations, robust CAPAs, and remediation plans.
• Support internal audits, customer audits, and regulatory inspections, including development and execution of responses and corrective action plans.

Skills

Leadership

Quality Systems

Stakeholder management

Strategic oversight

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Tools

TrackWise

MODA

SAP

Job description

Lonza in Walkersville, MD is hiring an Associate Director, Quality Assurance to lead the site Quality Systems and drive compliance across manufacturing operations. You will oversee change control, deviations, investigations, CAPA, complaints, document and label controls, and quality metrics while partnering with Quality, Manufacturing, Regulatory Affairs and site leadership.

The role requires a strong background in FDA, EU GMP, ISO 13485 and cGMP/cGxP regulations, plus experience guiding audits