GCP Inspection Lead, EMEA, Associate Director

BeOne Medicines Ltd.; Basel; On-site; CHF 149,000 - 186,000; Full time

Job summary

BeOne Medicines Ltd. in Basel-Stadt is seeking an experienced GCP Inspection Lead to drive inspection readiness for cross-functional clinical study teams and oversee inspection logistics and CAPA actions.

You will lead inspections from major health authorities, develop SOPs, manage risk, and mentor staff while ensuring compliance with global GCP requirements. Travel up to 35% is required; fluency in English is essential.

Qualifications

• 7–10 years of experience in GCP-related Quality Assurance in pharma/biotech
• Excellent English language skills (written and spoken)
• Strong leadership and mentoring abilities
• Ability to collaborate across cross-functional teams
• Attention to detail and ability to manage multiple tasks in a fast-paced environment

Responsibilities

• Lead inspection readiness activities for regulatory health authorities (FDA, EMA, CFDI, MFDS, PMDA, TGA, etc.)
• Plan and manage inspection logistics and post-inspection actions
• Develop SOPs and tools for inspection readiness
• Oversee CAPAs, deviations, investigations, and SQEs
• Mentor junior staff and lead lessons learned sessions

Skills

GCP QA leadership

English proficiency

Verbal and written communication

Collaboration

Mentoring

Leadership

Tools

MS Office

Audit Utopia

Job description

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.

Reporting to the Director, GCP Inspection Management, EMEA, the inspection lead will be primarily responsible for GCP Health Authority inspection readiness for cross-functional clinical study teams, managing inspection logistics and process improvements to ensure research and development activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established standards and practices.

• Supervise and manage activities related to inspection readiness, leading inspections conducted by regulatory health authorities such as FDA, EMA, CFDI, MFDS, PMDA, TGA, etc.
• Collaborate with cross-functional clinical study teams to ensure a unified approach to inspection readiness strategy.
• Manage Inspection Readiness Checklist, development of storyboards, identify and mitigate inspection risks, and facilitate/lead mock and actual inspections.
• During inspections, assign inspection requests to appropriate subject matter experts (SMEs) and provide guidance to ensure timely fulfillment.
• Create/revise appropriate SOPs and tools for inspection readiness and management.
• Implement and maintain key QA systems, including investigations, Significant Quality Events (SQEs), Deviations, and CAPAs.
• Demonstrate ability to solve complex problems requiring in-depth evaluation of various factors.
• Fulfill all inspection commitments, respond to inspections, and carry out post-inspection activities, corrective and preventative actions, and resolve any issues for timely closure.
• Manage a central repository of global inspection status and updates.
• Meticulous attention to detail, excellent reviewing skills, and ability to independently manage multiple tasks in a fast-paced environment.
• Support/manage pre-inspection visits at investigative sites.
• Lead and manage lessons learned sessions after inspections, identifying trends and best practices to implement process improvements.
• Proven ability to set strategies for and drive initiatives aimed at improving quality processes.
• Strong leadership skills and ability to mentor others.
• Thorough understanding of international regulations applicable to the conduct of clinical trial operations on a global scale.
• undefined

Supervisory Responsibilities

This position may include managing staff: coaching and mentoring of junior staff with training/orientation/qualification and development plan for new Quality staff when required. Therefore, it is required to have strong leadership experience and mentoring skills.

Computer Skills

PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint); Audit Utopia experience preferred.

Other Qualifications

• Minimum of 7-10 years of experience in GCP-related Quality Assurance function of the pharmaceutical, biotechnology or related health care industry.
• 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.
• Excellent verbal and written communication skills
• Ability to effectively collaborate in a dynamic environment.

Significant Contacts

• Quality Assurance
• Clinical Operations
• Pharmacovigilance
• Clinical Business Operations
• Biometrics
• Medical Monitors
• Regulatory Affairs
• Interacts with all levels of BeiGene

Travel

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

Salary Range Switzerland: 148,900.00 CHF - 186,100.00 CHF

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. BeOne 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.