Associate Director, Quality Assurance

Lonza•Walkersville, MD

1d•$168,000 - $196,000•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

Advanced degree preferred.

Responsibilities

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.