Senior Technical Quality Specialist - Validation & Compliance

Resilience, Inc.; Ohio; On-site; USD 100,000 - 144,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

Healthcare benefits

Paid vacation

Tuition reimbursement

Job summary

Resilience, Inc. in the United States is seeking a Senior Specialist II, Technical Quality to provide advanced quality oversight across investigations, validation, and technology transfer.

The role partners with MSAT, Engineering and Project Management to ensure compliant, efficient manufacturing processes. The candidate will lead complex deviations, CAPAs and risk assessments, support regulatory inspections, and drive continuous improvement while ensuring GMP, FDA and ICH adherence.

Qualifications

• Strong technical experience in the qualification of equipment, utilities, facilities, technology transfer and process validation.
• Thorough knowledge of current industry best practices and regulatory guidance expectations regarding technology transfer and validation.
• Strong leadership, relationship management, and organizational planning.
• Experience supporting audits and regulatory inspections.
• Experience using risk assessment tools (e.g. FMEA, HACCP, LOPA, PHA, Lean).
• Expertise in quality management systems.
• Excellent problem-solving skills and the ability to work under pressure in a fast-paced environment.
• Strong interpersonal skills with the ability to lead cross-functional teams and influence without direct authority.
• Excellent written and verbal communication skills, including technical writing for documents and reports.
• Ability and willingness to learn and adapt skills for various areas.
• Ability to travel approximately 5-10% based on project demand.
• Must have proficient computer skills and be experienced in Microsoft Office, including Word, Excel, PowerPoint, and Outlook.

Responsibilities

• Provide quality oversight for complex and/or higher-level investigations, validation protocols, and technology transfer documents, ensuring adherence to established specifications, procedures, and regulatory requirements.
• Provide quality oversight, review, and approval of complex and higher-level validation documents including validation plans, requirement documents (URS, FS, SRA, SLIA, and ACA), protocols, data analysis, discrepancies, and final reports.
• Represent the Technical Quality group in project teams, audits, and inspections, as required.
• Provide hands-on support and act as an SME and/or host during internal, regulatory, and customer audits and inspections.
• Perform reviews and approvals of investigation initial impact assessments to determine the classification of deviations.
• Provide quality oversight, review, and approval for deviations, CAPAs, Change Controls, and various risk assessments.
• In conjunction with the Lead Investigator, lead major/critical investigations and resolution of product quality issues and non-conformances, ensuring timely and effective corrective actions.
• Drive and support the development and implementation of continuous improvement initiatives to enhance product quality and manufacturing efficiency.
• Ensure manufacturing operations comply with local and global regulatory standards, including but not limited to GMP, FDA, EMA, and ICH guidelines.
• Collaborate with MSAT, Project Management, Engineering, and other departments to ensure seamless integration of new products and technologies into the manufacturing process.
• Assist in the review and approval of new product introductions, ensuring quality standards are met throughout the product lifecycle.
• Lead risk assessments (e.g. sFMEA) and implement strategies for mitigating technical and quality risks associated with manufacturing processes.

Skills

Quality oversight

Regulatory compliance

Validation

Technology transfer

Root cause analysis

Leadership

Audits

Problem solving

Cross-functional collaboration

GMP knowledge

Education

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

Tools

MS Office

Job description

Resilience, Inc. in the United States is seeking a Senior Specialist II, Technical Quality to provide advanced quality oversight across investigations, validation, and technology transfer.

The role partners with MSAT, Engineering and Project Management to ensure compliant, efficient manufacturing processes. The candidate will lead complex deviations, CAPAs and risk assessments, support regulatory inspections, and drive continuous improvement while ensuring GMP, FDA and ICH adherence.