Associate Director, Good Clinical Practice (GCP) Audits and Inspections

Be One 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.

General Description

The Associate Director, Good Clinical Practice (GCP) Audits and Inspections, within R&D Quality & Gx P Auditing, is a senior quality role responsible for leading and executing GCP audits, supporting regulatory inspection readiness and inspection activities, and providing quality oversight across assigned clinical development programs.

The role provides independent quality assurance and strategic GCP guidance to ensure compliance with applicable regulatory requirements, GCP standards, internal quality requirements, and contractual obligations, supporting the protection of clinical trial participants and the integrity of clinical research data.

The position collaborates with cross-functional stakeholders and Inspection Management to identify and mitigate compliance risks, support Health Authority inspections, and drive continuous improvement in GCP quality and inspection readiness.

The role may also provide quality leadership for assigned compounds or clinical development programs.

The Associate Director utilizes Veeva Vault and other applicable systems to support effective planning, documentation, tracking, and oversight of audit and inspection activities.

Key Responsibilities

• GCP Audits
• Lead and conduct risk-based GCP audits, including investigator site, vendor, process/system, internal, and for-cause audits, in accordance with approved audit plans and applicable procedures.
• Plan, prepare, conduct, document, and report audits, ensuring clear identification and communication of GCP compliance risks and observations.
• Evaluate responses to audit findings and associated corrective and preventive actions (CAPAs), and ensure appropriate follow-up and closure.
• Contribute to the development and execution of GCP audit strategies and plans based on regulatory, operational, and quality risks.
• Identify audit trends, systemic compliance risks, and opportunities for quality improvement.
• Inspection Readiness & Regulatory Inspections
• In collaboration with Inspection Management, lead or co-lead GCP inspection readiness activities and support Health Authority inspections.
• Partner with cross-functional clinical study teams and subject matter experts to develop and execute risk-based inspection readiness strategies.
• Support and/or lead inspection preparation activities, including inspection risk assessments, storyboards, mock inspections, and readiness assessments.
• During inspections, coordinate inspection requests and support SMEs in providing accurate, timely, and effective responses.
• Support post-inspection activities, including assessment and follow-up of inspection observations and associated CAPAs.
• Compound/Program Quality Oversight
• Provide GCP quality leadership and guidance for assigned compounds or clinical development programs.
• Partner with clinical development functions to proactively identify, assess, communicate, and mitigate significant GCP compliance and quality risks.
• Provide independent quality perspectives and strategic GCP advice to study and program stakeholders.
• Escalate significant or systemic quality and compliance risks, as appropriate.
• GCP Vendor Management & Oversight
• Provide GCP quality oversight of vendors supporting clinical development activities, including CROs and other GCP service providers.
• Support vendor qualification and ongoing risk-based quality oversight to ensure compliance with applicable GCP requirements, internal quality standards, and contractual quality obligations.
• Lead and/or conduct risk-based vendor audits and quality assessments and ensure appropriate follow-up of identified findings and CAPAs.
• Partner with Clinical Operations, Procurement, and other relevant stakeholders to identify, assess, communicate, and mitigate vendor-related GCP quality and compliance risks.
• Review vendor quality performance, compliance issues, deviations, and emerging trends, and elevate significant or systemic risks as appropriate.
• Provide GCP quality input into vendor governance and oversight activities and support continuous improvement of vendor performance and compliance.
• Utilize Veeva Vault and other applicable quality systems to document and track vendor audit and quality oversight activities.
• Leadership & Continuous Improvement
• Serve as a GCP subject matter expert and provide guidance to internal stakeholders on audit, inspection readiness, and GCP compliance matters.
• Build effective partnerships across Clinical Operations, Regulatory Affairs, Quality, and other relevant functions.
• Contribute to the development and continuous improvement of GCP audit and inspection processes, tools, and quality systems.
• Maintain awareness of evolving global GCP regulations, regulatory expectations, and industry practices.
• Mentor and provide guidance to auditors and other Quality personnel, as appropriate.
• Utilize Veeva Vault and other applicable quality systems for effective management and documentation of audit and inspection activities.

Qualifications & Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Business, or related field (Master’s preferred).
• Minimum 8 years of relevant experience in GCP Quality Assurance, GCP auditing, regulatory inspection support/management, Clinical Operations, or related pharmaceutical/biotechnology clinical research activities.
• Demonstrated experience conducting and leading GCP audits, including investigator site, vendor, process/system, and/or internal audits.
• Experience supporting or leading GCP regulatory inspection readiness and Health Authority inspection activities.
• Strong knowledge of ICH GCP, applicable global clinical trial regulations, and regulatory expectations.
• Demonstrated ability to identify, assess, communicate, and support mitigation of complex GCP compliance and quality risks.
• Excellent leadership, communication, analytical, and problem-solving skills.
• Ability to manage multiple projects and stakeholders in a fast-paced environment.
• Interacts with all levels of Bei Gene.
• Proficiency in relevant vendor management systems.
• PC literacy required: MS Office skills (Outlook, Word, Excel, Power Point)
• Preferred Qualifications
• Certification in GCP auditing or clinical research is a plus.
• Experience working with electronic Trial Master File (e TMF) and Clinical Trial Management Systems (CTMS).
• Familiarity with risk-based quality management (RBQM) principles.
• Advanced experience in Veeva Vault Quality Suite implementation and management.
• Supervisory Responsibilities
• This position may include managing staff (junior auditor): 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.
• 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.

Salary Range Switzerland: 148,900.00 CHF - 186,100.00 CHF Salary Range Netherlands: 105,800.00 EUR - 132,300.00 EUR Salary Range UK: 78,200.00 GBP - 97,800.00 GBP

• Global Competencies
• 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

We are proud to be an equal opportunity employer.

Be One does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.

All employment is decided on the basis of qualifications, merit, and business need.

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