Senior Technical Quality Lead – GMP & Validation

Resilience; Olde West Chester (OH); On-site; USD 100,000 - 144,000; Full time

Job summary

Resilience, a technology-focused biomanufacturing company, seeks a Technical Quality Senior Specialist II to lead QA oversight of validation, investigations, and tech transfer. You will collaborate across MSAT, Engineering, and PM to improve product quality while ensuring compliance with GMP, FDA, EMA, and ICH guidelines.

You will drive continuous improvement initiatives, review complex validation documents, and participate in audits. Travel up to 10% may be required.

Qualifications

• Strong QA oversight of complex investigations, validation and tech transfer.
• Experience with GMP/Regulatory expectations for tech transfer and validation.
• Proven ability to lead cross-functional teams and audits.

Responsibilities

• Provide quality oversight for complex investigations, validation protocols, and technology transfer documents, ensuring adherence to specs and regulatory requirements.
• Review and approve complex validation documents (URS, FS, SRA, SLIA, ACA) and final reports.
• Represent the Technical Quality group in project teams, audits, and inspections.
• Provide SME support during internal, regulatory, and customer audits and inspections.
• Lead risk assessments and classify deviations; drive corrective actions.
• Oversee deviations, CAPAs, Change Controls, and risk assessments.
• Drive continuous improvement initiatives to enhance product quality and manufacturing efficiency and ensure compliance.

Skills

Quality oversight

Regulatory compliance

GMP knowledge

Cross-functional leadership

Audits & inspections

Education

Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Engineering

Tools

MS Office

Job description

Resilience, a technology-focused biomanufacturing company, seeks a Technical Quality Senior Specialist II to lead QA oversight of validation, investigations, and tech transfer. You will collaborate across MSAT, Engineering, and PM to improve product quality while ensuring compliance with GMP, FDA, EMA, and ICH guidelines.

You will drive continuous improvement initiatives, review complex validation documents, and participate in audits. Travel up to 10% may be required.