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.
Essential Functions Of The Job
* Lead and oversee GCP Inspection readiness activities and serve as inspection lead for regulatory Health Authority inspections, including but not limited to FDA, MHRA, EMA, CFDI, MFDS, PMDA, TGA, and TFDA.
* Collaborate with cross‑functional clinical study teams to develop and execute an integrated, risk‑based inspection readiness strategy, ensuring consistent alignment across functions.
* Manage end‑to‑end inspection readiness activities, including development and maintenance of inspection storyboards with subject matter experts (SMEs), proactive identification and mitigation of inspection‑related risks, and planning, facilitation, and leadership of mock inspections and Health Authority inspections.
* During regulatory inspections, coordinate and assign inspection requests to appropriate SME), providing oversight and guidance to ensure accurate, timely, and effective responses.
* 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 Site Inspection Preparation Visit (SIPV) at investigative sites.
* Lead and facilitate post‑inspection lessons learned sessions to trends, share best practices, and drive sustainable process improvements.
* Demonstrate the ability to define strategic direction and lead initiatives that enhance quality systems, inspection readiness, and overall operational excellence.
* Exhibit strong leadership capabilities, including the ability to mentor, coach, and develop team members and cross‑functional partners.
* Possess a thorough understanding of global regulatory requirements and guidelines governing the conduct of clinical trial operations across multiple regions.
Supervisory Responsibilities
* Not Applicable
Computer Skills
All basic Microsoft Office Programs
Other Qualifications
* +7 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.
Travel
* Flexible to travel, including international.
* May require up to 35% travel, sometimes with short notice time.
Salary Range Switzerland: 141,800.00 CHF - 177,300.00 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.
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