Senior Quality Systems Lead - Audits & Compliance

Charles River Laboratories; Newark (DE); In loco; USD 39.000 - 55.000; Tempo pieno

Vantaggi offerti da questo lavoro

Bonus incentives

401K

Paid time off

Stock purchase program

Health and wellness coverage

Employee and family wellbeing support

Work life balance flexibility

Descrizione del lavoro

Charles River Laboratories in Newark, DE seeks a seasoned Quality Assurance professional to ensure compliance with applicable regulations and SOPs, lead audit preparations, and support continuous improvement within the QMS. The role includes customer-facing audit coordination and cross-site QA activities.

The candidate will review quality records, participate in inspections, and contribute to CAPA and change controls while maintaining high standards of documentation and regulatory alignment.

Competenze

• Bachelor’s degree in life sciences or equivalent.
• Minimum of 8 years in a Quality Assurance role or regulated industry.
• Proficient in Microsoft Office and spreadsheet/database tools such as Access and Excel; strong writing skills.

Mansioni

• Ensure regulatory compliance across federal, state, and local requirements.
• Lead QA file preparation for client audits and regulatory inspections.
• Review SOPs, protocols, deviations, and CAPA for complex issues.
• Coordinate quality metrics reporting and QMS improvements.
• Provide QA support for validation of software, rooms, and equipment.

Conoscenze

Quality Assurance

Regulatory compliance

Documentation

Audit readiness

Attention to detail

Formazione

Bachelor's degree in life sciences

Strumenti

Microsoft Office

Access

Excel

Descrizione del lavoro

Charles River Laboratories in Newark, DE seeks a seasoned Quality Assurance professional to ensure compliance with applicable regulations and SOPs, lead audit preparations, and support continuous improvement within the QMS. The role includes customer-facing audit coordination and cross-site QA activities.

The candidate will review quality records, participate in inspections, and contribute to CAPA and change controls while maintaining high standards of documentation and regulatory alignment.