Senior Manager, GCP Auditor

Job Title: Senior Manager, GCP Auditor

Job Location: Japan

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

About us

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing,and Cambridge, U.S. To learn more about BeOne, please visitwww.beonemedicines.comand follow us on LinkedIn and X (formerly known as Twitter).

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Job Description:

This position within R&D Quality is a senior Auditor role (as Lead or Co-auditor) who is responsible for independently overseeing and conducting GCP audits, to ensure compliance with GCP 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 clinical research processes and data.

This position requires:

• Extensive knowledge and/or awareness of ICH GCP and applicable global & local regulations and guidance for clinical development.

• Strong global mindset and knowledge about regulations (specific expertise regulations/ requirements/ culture awareness)

• Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.

• Extensive experience in managing GCP investigations.

• Experience in product/compound lead/consultancy (GCP)

• Extensive or Direct experience with supporting and involvement in GCP inspections (main inspectorates (FDA, EMA, CFDI etc.,)) and other country specific inspectorates (MFDS, PMDA, TGA etc., based on location of position)

• Provide GCP guidance for all phases of drug development for assigned clinical compounds/projects.

• Lead or support development of GCP quality metrics and measures to drive assessment and continuous improvement.

• Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems.

• Effective technical writing skills; able to write quality positions, audit reports, and procedures.

• Excellent communication skills with ability to negotiate and influence without authority in a matrix environment.

• Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines.

Essential Functions of the job:

• Audit Planning & Preparation : Operationalize approved audit plans and strategies for R&D GCP 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 (routine, for-cause/directed); Evaluate compliance with GCP 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.

• Support the process of developing audit programs for clinical studies and oversee the programs on a quarterly basis or as required.

• R&D GCP Quality Assurance Compound Lead: Take the role as one of R&D Quality GCP Quality Assurance Compound Leads (R&D GCP QACL), to provide strategic GCP quality oversight and support to clinical development activities, for the assigned compounds/studies.

• 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).

• Lead or support development of GCP quality metrics and measures to drive assessment and continuous improvement.

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

Qualification Required:

Education Required:

• BA/BS degree required; advanced degree preferred.

• GCP Quality Assurance auditor’s registration/certification preferred.

Supervisory Responsibilities:

• The senior manager position may include coaching and mentoring of junior auditors, with training/orientation/qualification and development plan for new Quality staff, required. Therefore, it may require to have certain leadership experience and mentoring skills. 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 7-10 years of experience in GCP-related Quality function of the pharmaceutical, biotechnology or related health care industry, preferably with experience in managing GCP inspections.

• Minimum 3-5 years as GCP auditors (external and internal audits) and relevant clinical trial experience.

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

• High level of understanding of international GCP 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/BeOne.

Travel:

• Flexible to travel, including international.

• May require up to 35% travel, sometimes with short notice time.

• Audit travel mostly overnight for on-site audits is required - anticipating min 2 audits/month.

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme

• Company shares (generous welcome grant!)

• In-house and external learning and development opportunities

• Fantastic benefits program and keep improving!

• Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.

• Join us and Make momentum in your career!

BeOne Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork

• Provides and Solicits Honest and Actionable Feedback

• Self-Awareness

• Acts Inclusively

• Demonstrates Initiative

• Entrepreneurial Mindset

• Continuous Learning

• Embraces Change

• Results-Oriented

• Analytical Thinking/Data Analysis

• Financial Excellence

• Communicates with Clarity

BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy ().

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.

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Originally posted on Himalayas