Quality Compliance & Client Liaison Expert

Resilience; Port Union (OH); On-site; USD 100,000 - 144,000; Full time

Job summary

Resilience is a technology-focused biomanufacturing company committed to delivering high-quality, compliant solutions for pharmaceutical clients. The Senior Specialist II will lead site Quality Compliance processes and act as the primary quality liaison for client communications, quality agreements, and audits throughout the product lifecycle.

This role oversees self-inspections, QAAs, SOPs, and metrics reporting, guiding cross-functional teams to mitigate risks and ensure regulatory readiness.

Qualifications

• Bachelor's degree in science/engineering; advanced degree preferred.
• Strong knowledge of cGMP in Pharma/Biotech.
• Experience with QA/regulatory compliance and inspections.
• Excellent written and verbal communication.
• Ability to lead multidisciplinary teams.

Responsibilities

• Lead client quality management activities and QAAs.
• Oversee site self-inspection program and CAPA follow-up.
• Develop SOPs and quality oversight documents.
• Provide quality metrics and risk mitigation updates to clients.
• Coordinate client communications and visits related to quality.

Skills

Quality leadership

Project management

Technical writing

Interpersonal skills

QA problem solving

Regulatory knowledge

Education

Bachelor's degree in science/engineering

MBA/advanced degree

Tools

SAP

Empower

LIMS

Job description

Resilience is a technology-focused biomanufacturing company committed to delivering high-quality, compliant solutions for pharmaceutical clients. The Senior Specialist II will lead site Quality Compliance processes and act as the primary quality liaison for client communications, quality agreements, and audits throughout the product lifecycle.

This role oversees self-inspections, QAAs, SOPs, and metrics reporting, guiding cross-functional teams to mitigate risks and ensure regulatory readiness.