Associate Director, Quality Assurance

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

Associate Director, Quality Assurance

United States, Walkersville (Maryland)

Location:

This position is based in our Walkersville, MD office. The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.

What You Will Get

The full-time base annual salary for this position is expected to range between $168,000 to $196,000.

• 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).

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What Will You Do

The Associate Director, Quality Assurance is responsible for leadership and oversight of the site Quality Systems organization. This role ensures the effectiveness, compliance, and continuous improvement of key Quality Management System (QMS) processes supporting medical device, media, and LAL manufacturing operations. The position leads a team responsible for the ownership and execution of change controls, deviations, investigations, CAPAs, complaints, effectiveness checks, compliance monitoring, and quality metrics. The Associate Director will work cross-functionally with Quality, Manufacturing, Technical Operations, Regulatory Affairs, and site leadership to maintain a robust and inspection-ready quality system.

• Lead and develop a team of approximately 5-10 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 sustainable remediation plans.
• Support internal audits, customer audits, and regulatory inspections, including the development and execution of responses and corrective action plans.
• Maintain a culture of quality, compliance, accountability, and continuous improvement throughout the organization.
• Develop departmental objectives, resource plans, and budgets to support current operations and future business growth.
• Review high-risk deviations, investigations, complaints, and change controls, escalating significant quality risks to site leadership as appropriate.
• Perform other duties as assigned.

What We Are Looking For

• Bachelor's degree in Life Sciences, Engineering, Chemistry, Microbiology, or related discipline; advanced degree preferred.
• 10+ years of Quality Assurance experience within pharmaceutical, biotechnology, medical device, cell therapy, or other regulated manufacturing environments.
• 5+ years of leadership experience managing Quality Systems functions and high-performing teams.
• Demonstrated expertise with Quality Management Systems, including Change Control, Deviations, Investigations, CAPA, Customer Complaints, Risk Management, and Compliance programs.
• Strong understanding of FDA, EU GMP, ISO 13485, and applicable cGMP/cGxP regulations.
• Experience serving as a Quality Systems process owner and driving quality system improvements within a complex manufacturing environment.
• Proven ability to analyze quality metrics and trends, identify compliance risks, and implement sustainable solutions.
• Experience supporting regulatory inspections, customer audits, and responses to regulatory observations.
• Proficiency with electronic Quality Management Systems such as TrackWise, MODA, SAP, and other validated business systems.
• Strong communication and stakeholder management skills with the ability to influence leaders across multiple functions and organizational levels.
• Demonstrated ability to lead organizational change, build high-performing teams, and foster a culture of continuous improvement.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Reference: R79142