General Description:

　　This position within R&D Quality is a senior role who is responsible for independently overseeing and conducting GVP audits, to ensure compliance with GVP regulations and industry standards, in accordance with applicable regulatory requirements, guidelines, laws and internally established standards and practices.

　　The position will play a critical role in safeguarding the integrity, safety, and quality of pharmacovigilance processes and data.

　　This position requires:

　　Expert knowledge of GVP requirements

　　Extensive experience in PVQA

　　Independent, able to prepare/lead PV inspections (should have a global mindset and knowledge about regulations (specific expertise regulations/requirements/culture)

　　Ability to work with inspection tools (e.g., Audit Utopia)

　　Experience in running PV Tactical audit plan etc.

　　Extensive experience in PV audit Conduct (Vendors, Affiliates, internal/System audits, Partner audits, Data audits etc.)

　　Supporting the activities related to the vendor qualification, management, process training, SOPs, etc.

　　Experience with PV QMRs

　　Maintaining Key QA systems, such as investigations, Significant Quality Events (SQEs), Deviations, CAPAs, Audits

　　Conducting/managing review of key PV documents

　　Developing quality metrics and measures to drive assessment and continuous improvement

　　Coordinate and/or administer GCP/GVP training, as needed

　　Essential Functions of the job:

　　Audit Planning & Preparation: Operationalize approved audit plans and strategies for R&D GVP audits (External & Internal audits), considering relevant regulations and industry standards; Coordinate audit schedules and necessary resources with relevant stakeholders: Review documentation, procedures, and quality management systems prior to conducting audits.

　　Conducting Audit: Perform on-site or remote audits; Evaluate compliance with GVP regulations, internal quality standards, and relevant guidelines; Document audit findings, deviations, and areas of non-compliance; Interview personnel, review records, and gather evidence during audits.

　　Reporting & Documentation: Prepare comprehensive audit reports outlining findings, observations, and recommendations for corrective actions; Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures and ensure effective CAPA are provided by auditee; maintain well-organized and accurate audit documentation for regulatory and internal purposes.

　　Escalate systemic, critical and/or major audit findings and recommend appropriate solutions to senior management for immediate and long-term resolution.

　　Work with leadership to establish processes and standards for excellence in R&D audits, responses, CAPAs and effectiveness checks to optimize effective and consistent performance within R&D Quality and for R&D stakeholders.

　　Participate in & support GCP, GVP & GLP authority inspections (FDA, EMA, PMDA, TGA, CFDI etc.,) in assigned roles such as back-room support, inspection hosting support, inspection & pre-inspection preparation support (site and sponsor).

　　Provide professional expertise and strong leadership in GVP guidance and regulations to internal stakeholder with R&D Quality and other functions within the company.

　　Supervisory Responsibilities:

　　This position may include: coaching and mentoring of junior auditors, with training/orientation/qualification and development plan for new Quality staff, if required. It also includes management of contract auditors.

　　Mentor and provide support to R&D auditors personnel, as needed.

　　Computer Skills: PC literacy required: MS Office skills (Outlook, Word, Excel, PowerPoint)

　　Other Qualifications:

　　Minimum of 3-5 years of experience in GVP-related Quality Assurance function of the pharmaceutical, biotechnology or related health care industry.

　　Minimum 2-3 years as GVP auditors (external and internal audits) and relevant PV auditing experience.

　　Minimum 3-5 years of direct involvement to support or participation in GVP authority inspections.

　　High level of understanding of international GVP requirements and standards in the pharmaceutical, medical device and biotech industries.

　　Excellent English language skills, and additional language depending on locations and need, e.g., /. Spanish for LATAM, German, French, etc., for Europe)

　　Excellent verbal and written communication skills

　　Ability to effectively collaborate in a dynamic environment.

　　Interacts with all levels of BeiGene.

　　Travel:

　　Flexible to travel.

　　May require up to 30-40% travel, sometimes with short notice time.

　　Audit travel is required - anticipating min 2 audits/month.

　　All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.