Senior Specialist II, Technical Quality (sterile Ops)

Technical Quality Senior Specialist II

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

Position Summary: The Technical Quality Senior Specialist II plays a pivotal role in ensuring the technical and operational quality of products, driving continuous improvement in manufacturing processes, and ensuring compliance with regulatory standards. This position requires a blend of strong technical expertise, quality assurance knowledge, and leadership capabilities to effectively collaborate across departments and lead initiatives that enhance product quality and process efficiency. The Senior Specialist II has advanced technical expertise to be able to provide quality oversight of validation, investigations, and technology transfer. They may work independently or lead specialized projects in their area of expertise, providing high-level strategic insight and technical advice.

Job 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.

Minimum Qualifications:

• Strong technical experience in the qualification of equipment, utilities, facilities, technology transfer and process validation, and/or Quality oversight in these disciplines.
• 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. Failure Modes and Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), Layers of Protection Analysis (LOPA), Preliminary Hazard Analysis (PHA), simple Lean tools, etc.).
• Expertise in quality management systems.
• Excellent problem-solving skills and the ability to w