Senior Manager, GCP Inspection Lead

pBeOne 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. /ppReporting to the Senior Director, Global GCP Inspection Management, RD Quality, the Senior Manager, Inspection Management serves as an inspection lead with primary responsibility for Health Authority GCP inspection readiness across cross‑functional clinical study teams. /ppThis role oversees end‑to‑end inspection planning and execution, including inspection logistics, stakeholder coordination, and continuous process improvements, to ensure research and development activities comply with applicable global regulatory requirements, guidelines, laws, and internal standards and practices. /ph3Essential Functions of the job: /h3ulliLead 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. /liliCollaborate with cross‑functional clinical study teams to develop and execute an integrated, risk‑based inspection readiness strategy, ensuring consistent alignment across functions. /liliManage 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. /liliDuring regulatory inspections, coordinate and assign inspection requests to appropriate SME), providing oversight and guidance to ensure accurate, timely, and effective responses. /liliCreate/revise appropriate SOPs and tools for inspection readiness and management. /liliImplement and maintain key QA systems, including investigations, Significant Quality Events (SQEs), Deviations, and CAPAs. /liliDemonstrate ability to solve complex problems requiring in-depth evaluation of various factors. /liliFulfill all inspection commitments, respond to inspections, and carry out post‑inspection activities, corrective and preventative actions, and resolve any issues for timely closure. /liliManage a central repository of global inspection status and updates. /liliMeticulous attention to detail, excellent reviewing skills, and ability to independently manage multiple tasks in a fast‑paced environment. /liliSupport/manage Site Inspection Preparation Visit (SIPV) at investigative sites. /liliLead and facilitate post‑inspection lessons learned sessions to trends, share best practices, and drive sustainable process improvements. /liliDemonstrate the ability to define strategic direction and lead initiatives that enhance quality systems, inspection readiness, and overall operational excellence. /liliExhibit strong leadership capabilities, including the ability to mentor, coach, and develop team members and cross‑functional partners. /liliPossess a thorough understanding of global regulatory requirements and guidelines governing the conduct of clinical trial operations across multiple regions. /li /ulh3Supervisory Responsibilities: /h3pNot Applicable /ph3Computer Skills: /h3pAll basic Microsoft Office Programs /ph3Other Qualifications: /h3ulli+7 years of experience in GCP‑related Quality Assurance function of the pharmaceutical, biotechnology or related health care industry. /liliHigh level of understanding of international GCP requirements and standards in the pharmaceutical, medical device and biotech industries. /liliExcellent English language skills, and additional language depending on locations and need. /liliExcellent verbal and written communication skills Ability to effectively collaborate in a dynamic environment. /li /ulh3Travel: /h3pFlexible to travel, including international. May require up to 35% travel, sometimes with short notice time. /ph3Salary Range Switzerland: /h3p141,800.00 CHF - 177,300.00 CHF /ph3Global Competencies: /h3pWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. /pulliFosters Teamwork /liliProvides and Solicits Honest and Actionable Feedback /liliSelf‑Awareness /liliActs Inclusively /liliDemonstrates Initiative /liliEntrepreneurial Mindset /liliContinuous Learning /liliEmbraces Change /liliResults‑Oriented Analytical Thinking/Data Analysis /liliFinancial Excellence /liliCommunicates with Clarity /li /ulpWe 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. /ppBeOne 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 11,000 colleagues spans six continents. /ppTo learn more about BeOne, please visit and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram. /ppFor more information, please visit the link to explore job opportunities in China Mainland. /ph3China Mainland Job Posting /h3pAt BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Driving Excellence Bold Ingenuity Collaborative Spirit /p #J-18808-Ljbffr