Senior Manager, Global R&D Audits & Inspections Readiness

Job overview

The Senior Manager, Global R&D Audits & Inspections Readiness is an onsite role in San Mateo, CA. Compensation is not specified. The role supports BeOne Medicines’ research and development technology solutions and regulatory readiness. The manager coordinates practical compliance and inspection-readiness execution across systems, products, vendors, and stakeholders. The work embeds validation, data integrity, and quality expectations into technology delivery and operational processes to support compliant R&D systems.

What you'll do

• Coordinate validation-by-design activities and validation documentation
• align automated testing and release controls with audit-ready evidence
• lead assigned audit and inspection readiness workstreams
• prepare system narratives and evidence packages
• coach stakeholders on audit protocols
• support vendor and SaaS compliance reviews
• translate regulatory expectations into technical actions
• track CAPA, remediation, readiness metrics, and compliance risks.

What we're looking for

Skills & competencies

senior manager

global r&d

audits

inspections readiness

san mateo ca

beone medicines

gxp compliance

computerized systems validation

computer software assurance

agile delivery

capa tracking

vendor compliance

regulatory readiness

Work arrangement

• Weekend coverage required

Why this role

No direct line-management responsibilities are required. The role may coordinate matrixed contributors and vendors. Some travel is expected as part of assigned duties.

About the employer

BeOne Medicines is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.