Sr Associate II, Technical Quality

About This Role

As a Senior Associate II, Technical Quality, you will play a critical role in ensuring quality and compliance across manufacturing, laboratory, engineering, and quality operations. You will lead and support investigations, change controls, quality oversight activities, and continuous improvement initiatives that strengthen operational performance and regulatory compliance. This position serves as a key technical quality subject matter expert, partnering cross-functionally to solve complex problems, assess risk, and implement effective quality solutions. You will provide quality assurance oversight for quality control activities, technology transfers, material management, and regulatory inspection readiness. This role helps drive a culture of quality, compliance, and operational excellence across the organization.

What You’ll Do

• Lead, review, and approve deviation investigations and ensure timely resolution of quality events
• Assess deviation impact, identify root causes, and support effective CAPA implementation
• Manage change controls related to raw materials, supplier changes, and material lifecycle activities
• Provide Quality Assurance oversight of Quality Control operations, laboratory systems, and analytical activities
• Review and approve investigations related to OOS, OOT, atypical, and invalid laboratory results
• Perform material disposition activities in accordance with approved procedures
• Review and approve technology transfer protocols, reports, and technical documentation
• Support internal audits, regulatory inspections, and third-party audits
• Serve as a quality representative on cross-functional projects and continuous improvement initiatives
• Provide technical guidance on GMP compliance, quality systems, and regulatory expectations

Who You Are

You are a collaborative quality professional who thrives in complex GMP environments and enjoys solving technical and compliance challenges. You are a proactive leader who can influence cross-functional teams, make risk-based decisions, and drive continuous improvement.

Required Skills

• Bachelor's Degree plus minimum of 5 years of experience working in cGMP biotech or pharma quality positions
• GMP and quality systems expertise
• Demonstrated abilities in deviation investigation and root cause analysis
• Experience with process validation or QC method/instrument validation
• Change control management
• Regulatory compliance knowledge (FDA, EMA, ANVISA)
• Data integrity and laboratory systems knowledge

Preferred Skills

• Experience supporting regulatory inspections and audits
• Technology transfer experience
• Experience with enrollment testing and release of raw materials
• Quality Control experience