GCP Auditor, Senior Manager, R&D Quality

BeOne Medicines; São Paulo; Híbrido; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

An innovative firm is seeking a Senior Manager for GCP Auditing within R&D Quality. This role offers the chance to lead compliance audits that safeguard clinical research integrity. Ideal candidates will have extensive experience in the pharmaceutical or biotech industry, with a strong focus on GCP standards. The position emphasizes collaboration and effective communication, allowing you to mentor junior auditors while ensuring high-quality standards. If you're passionate about making a difference in cancer research, this opportunity is perfect for you.

Qualificações

• At least 7 years in GCP QA in pharma/biotech.
• 3+ years as GCP auditor experience.

Responsabilidades

• Conducting audits to ensure compliance with GCP.
• Reporting and documenting audit findings.

Conhecimentos

GCP Standards

Communication Skills

Collaboration Skills

Pharmaceutical/Biotech Experience

Formação académica

BA/BS Degree

Advanced Degree

GCP Quality Assurance Certification

Ferramentas

MS Office

Descrição da oferta de emprego

GCP Auditor, Senior Manager, R&D Quality

Join to apply for the GCP Auditor, Senior Manager, R&D Quality role at BeOne Medicines.

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd., subject to shareholder approval. During this transition, both names may be used. BeOne is growing rapidly and offers exciting opportunities for experienced professionals who are motivated, collaborative, and passionate about fighting cancer.

PLEASE SUBMIT ALL RESUMES/CVs IN ENGLISH FOR CONSIDERATION.

Location: Sao Paulo (Hybrid)

Language Requirement: English required; Spanish is a plus.

Required Experience: Pharmaceutical/Biotech Industry

General Description

This senior Auditor role within R&D Quality involves overseeing and conducting GCP audits to ensure compliance with regulations and standards, safeguarding the integrity of clinical research processes and data.

Key Responsibilities

• Audit Planning & Preparation
• Conducting Audits
• Reporting & Documentation
• Escalating critical findings
• Establishing audit processes and standards
• Supporting GCP inspections
• Providing expertise and leadership in GCP regulations

Minimum Requirements

• BA/BS degree; advanced degree preferred
• GCP Quality Assurance certification preferred
• At least 7 years in GCP QA in pharma/biotech
• 3+ years as GCP auditor experience

Other Qualifications

• Strong knowledge of GCP standards
• Excellent English skills; additional languages a plus
• Effective communication and collaboration skills

Supervisory Responsibilities

May include managing and mentoring junior auditors and contract staff.

Travel

Up to 35% travel, including international, with short notice.

Computer Skills

Proficiency in MS Office.

Global Competencies

Values such as teamwork, feedback, inclusivity, initiative, and continuous learning are emphasized.

Additional Details

Seniority Level: Mid-Senior level

Employment Type: Full-time

Job Function: Accounting/Auditing and Finance