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. /p pReporting 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. This 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. /p h3Essential Functions Of The Job /h3 ul liLead 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. /li liCollaborate with cross‑functional clinical study teams to develop and execute an integrated, risk‑based inspection readiness strategy, ensuring consistent alignment across functions. /li liManage 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. /li liDuring regulatory inspections, coordinate and assign inspection requests to appropriate SME), providing oversight and guidance to ensure accurate, timely, and effective responses. /li liCreate/revise appropriate SOPs and tools for inspection readiness and management. /li liImplement and maintain key QA systems, including investigations, Significant Quality Events (SQEs), Deviations, and CAPAs. /li liDemonstrate ability to solve complex problems requiring in-depth evaluation of various factors. /li liFulfill all inspection commitments, respond to inspections, and carry out post‑inspection activities, corrective and preventative actions, and resolve any issues for timely closure. /li liManage a central repository of global inspection status and updates. /li liMeticulous attention to detail, excellent reviewing skills, and ability to independently manage multiple tasks in a fast‑paced environment. /li liSupport/manage Site Inspection Preparation Visit (SIPV) at investigative sites. /li liLead and facilitate post‑inspection lessons learned sessions to trends, share best practices, and drive sustainable process improvements. /li liDemonstrate the ability to define strategic direction and lead initiatives that enhance quality systems, inspection readiness, and overall operational excellence. /li liExhibit strong leadership capabilities, including the ability to mentor, coach, and develop team members and cross‑functional partners. /li liPossess a thorough understanding of global regulatory requirements and guidelines governing the conduct of clinical trial operations across multiple regions. /li /ul h3Supervisory Responsibilities /h3 ul liNot Applicable /li /ul h3Computer Skills: /h3 pAll basic Microsoft Office Programs /p h3Other Qualifications /h3 ul li+7 years of experience in GCP‑related Quality Assurance function of the pharmaceutical, biotechnology or related health care industry. /li liHigh level of understanding of international GCP requirements and standards in the pharmaceutical, medical device and biotech industries. /li liExcellent English language skills, and additional language depending on locations and need. /li liExcellent verbal and written communication skills /li liAbility to effectively collaborate in a dynamic environment. /li /ul h3Travel /h3 ul liFlexible to travel, including international. /li liMay require up to 35% travel, sometimes with short notice time. /li /ul pSalary Range Switzerland: 141,800.00 CHF - 177,300.00 CHF /p h3Global Competencies /h3 pWhen 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. /p ul liFosters Teamwork /li liProvides and Solicits Honest and Actionable Feedback /li liSelf‑Awareness /li liActs Inclusively /li liDemonstrates Initiative /li liEntrepreneurial Mindset /li liContinuous Learning /li liEmbraces Change /li liResults‑Oriented /li liAnalytical Thinking/Data Analysis /li liFinancial Excellence /li liCommunicates with Clarity /li /ul pWe 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. /p #J-18808-Ljbffr