QA Strategy Lead - Associate Director, Quality Assurance

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

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance and disability coverage

Employee assistance programs

Paid time off (PTO)

Job summary

Lonza Group Ltd. in Walkersville, MD, is seeking an Associate Director of Quality Assurance to lead the site Quality Systems.

The role oversees change controls, investigations, CAPAs, and quality metrics, ensuring compliance and continuous improvement across medical device, media, and LAL manufacturing operations. You will lead a team of 5-10 quality professionals, partner with site leaders, and drive risk assessments and timely closure of Quality System records.

Qualifications

• 10+ years of Quality Assurance experience in regulated manufacturing environments.
• 5+ years in leadership managing Quality Systems functions.
• Expertise with QMS including Change Control, Deviations, Investigations, CAPA, Customer Complaints.
• Strong knowledge of FDA, EU GMP, ISO 13485 and cGXP regulations.
• Experience supporting regulatory inspections and audits.

Responsibilities

• Lead site Quality Systems organization; ensure effectiveness, compliance, and continuous improvement.
• Oversee Change Control, Deviations, Investigations, CAPA, complaints and metrics.
• Collaborate with Quality, Manufacturing, Regulatory Affairs and leadership.
• Provide coaching to 5-10 quality professionals and drive remediation plans.
• Support internal/customer/regulatory audits and responses.

Skills

Leadership

Quality mindset

Communication

Stakeholder management

Risk management

Data analysis

Education

Bachelor's degree in Life Sciences or related

Advanced degree preferred

Tools

TrackWise

MODA

SAP

Job description

Lonza Group Ltd. in Walkersville, MD, is seeking an Associate Director of Quality Assurance to lead the site Quality Systems.

The role oversees change controls, investigations, CAPAs, and quality metrics, ensuring compliance and continuous improvement across medical device, media, and LAL manufacturing operations. You will lead a team of 5-10 quality professionals, partner with site leaders, and drive risk assessments and timely closure of Quality System records.