Senior QA Lead – DSM, cGMP & Regulatory Compliance

Olon Ricerca Bioscience Llc; Concord (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Olon Ricerca Bioscience Llc in Concord, OH is seeking a Senior Quality Assurance Specialist to drive quality oversight for Drug Substance Manufacturing (DSM) processes through commercial release. The role focuses on QA oversight of day-to-day activities and mitigation of issues in a cGMP FDA-regulated facility.

You will collaborate with chemical engineers, organic chemists and analytical chemists across sites, lead QA documents development, validate processes, and support regulatory inspections.

Qualifications

• Bachelor's degree in a technical discipline required; GMP experience preferred.
• Minimum 5 years of relevant chemical processing experience.
• Experience in validation, cGMP manufacturing operations or quality oversight in FDA-regulated facilities.

Responsibilities

• Lead the QA team on DSM program documents, processes and procedures.
• Assess changes to systems and processes, ensuring validated state from startup to commercial operation.
• Oversee lifecycle documentation: risk assessments, specs, validation plans and summaries.
• Approve QA procedures and lifecycle documents for validation approaches.
• Provide QA support for manufacturing operations in a cGMP facility.
• Meet project timelines and quality objectives across sites.
• Collaborate with global peers to streamline processes and improve efficiency.
• Support regulatory inspections and internal audits.

Skills

Communication skills

English fluency

Time management

Problem solving

Regulatory knowledge

Education

B.S. in Chemical Engineering, Chemistry or technical disciplines

5+ years in GMP regulated environment

Job description

Olon Ricerca Bioscience Llc in Concord, OH is seeking a Senior Quality Assurance Specialist to drive quality oversight for Drug Substance Manufacturing (DSM) processes through commercial release. The role focuses on QA oversight of day-to-day activities and mitigation of issues in a cGMP FDA-regulated facility.

You will collaborate with chemical engineers, organic chemists and analytical chemists across sites, lead QA documents development, validate processes, and support regulatory inspections.