Senior Technical Quality Lead: Validation & Tech Transfer

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

Benefits offered by this job

Annual bonus program

401(k) with company match

Health, dental, vision

Job summary

Resilience, Inc. seeks a Technical Quality Senior Specialist II to drive manufacturing quality, lead complex investigations, validation, and technology transfer, and ensure GMP compliance across global operations.

You will act as SME, oversee deviations, CAPAs, risk assessments, and continuous improvement initiatives, collaborating with MSAT, Engineering, and QA to optimize product quality and manufacturing efficiency.

Qualifications

• 8+ years of total combined experience in quality assurance and/or validation within GMP regulated pharmaceutical and/or biotechnology manufacturing environment.
• Direct experience with GMP regulatory requirements relevant to pharmaceutical manufacturing.
• Proven track record in technical troubleshooting and root cause analysis.

Responsibilities

• Provide quality oversight for complex investigations, validation protocols, and technology transfer documents.
• Lead reviews/approvals of validation plans, URS/FS/SRA, protocols, data analyses, discrepancies, and final reports.
• Act as SME in audits/inspections and drive continuous improvement initiatives to enhance product quality and manufacturing efficiency.

Skills

Leadership

Cross-functional teams

Regulatory knowledge

Problem solving

Communication

Root cause analysis

GMP expertise

Education

Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences, or related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Job description

Resilience, Inc. seeks a Technical Quality Senior Specialist II to drive manufacturing quality, lead complex investigations, validation, and technology transfer, and ensure GMP compliance across global operations.

You will act as SME, oversee deviations, CAPAs, risk assessments, and continuous improvement initiatives, collaborating with MSAT, Engineering, and QA to optimize product quality and manufacturing efficiency.