Senior Technical Quality Lead: Validation & Compliance

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

Benefits offered by this job

Annual cash bonus

401(k) plan with company match

Comprehensive healthcare

Job summary

Resilience, a technology-focused biomanufacturing company, seeks a Technical Quality Senior Specialist II to oversee complex investigations, validation, and technology transfer. You will ensure GMP compliance and provide high-level technical guidance across manufacturing and QA teams.

Lead audits, support regulatory inspections, and drive continuous improvement in product quality and process efficiency. Collaboration with MSAT, Engineering, and Project Management is essential for successful

Qualifications

• Strong QA and regulatory compliance knowledge in GMP environments.
• Experience leading investigations, validation, and tech transfer.
• Proven ability to manage audits and inspections.
• Excellent problem-solving and communication skills.

Responsibilities

• Provide quality oversight for complex investigations, validation protocols, and technology transfer documents.
• Review and approve complex validation documents including URS, FS, SRA, SLIA, ACA, and reports.
• Attend audits and inspections as a Quality representative and SME.
• Support audits and host customer/regulatory inspections.
• Lead risk assessments (e.g., FMEA, HACCP, LOPA) and mitigation actions.
• Drive continuous improvement to enhance product quality and manufacturing efficiency.
• Collaborate with MSAT, Project Management, and Engineering for smooth tech integration.

Skills

Quality assurance

Regulatory compliance

Root cause analysis

Leadership

Audits

Risk assessment

Documentation and technical writing

Education

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

Tools

Microsoft Office

Job description

Resilience, a technology-focused biomanufacturing company, seeks a Technical Quality Senior Specialist II to oversee complex investigations, validation, and technology transfer. You will ensure GMP compliance and provide high-level technical guidance across manufacturing and QA teams.

Lead audits, support regulatory inspections, and drive continuous improvement in product quality and process efficiency. Collaboration with MSAT, Engineering, and Project Management is essential for successful