Senior Manager, GCP Inspection Lead

Das ist der Job

pBeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals.

Darum lohnt es sich

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.

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. /ppbEssential Functions of the job: /b /plipLead 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. /p /lilipCollaborate with cross-functional clinical study teams to develop and execute an integrated, risk‑based inspection readiness strategy, ensuring consistent alignment across functions. /p /lilipManage 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. /p /lilipDuring regulatory inspections, coordinate and assign inspection requests to appropriate SME), providing oversight and guidance to ensure accurate, timely, and effective responses. /p /lilipCreate/revise appropriate SOPs and tools for inspection readiness and management. /p /lilipImplement and maintain key QA systems, including investigations, Significant Quality Events (SQEs), Deviations, and CAPAs. /p /lilipDemonstrate ability to solve complex problems requiring in-depth evaluation of various factors. /p /lilipFulfill all inspection commitments, respond to inspections, and carry out post-inspection activities, corrective and preventative actions, and resolve any issues for timely closure. /p /lilipManage a central repository of global inspection status and updates. /p /lilipMeticulous attention to detail, excellent reviewing skills, and ability to independently manage multiple tasks in a fast-paced environment. /p /lilipSupport/manage Site Inspection Preparation Visit (SIPV) at investigative sites. /p /lilipLead and facilitate post-inspection lessons learned sessions to trends, share best practices, and drive sustainable process improvements. /p /lilipDemonstrate the ability to define strategic direction and lead initiatives that enhance quality systems, inspection readiness, and overall operational excellence. /p /lilipExhibit strong leadership capabilities, including the ability to mentor, coach, and develop team members and cross‑functional partners. /p /lilipPossess a thorough understanding of global regulatory requirements and guidelines governing the conduct of clinical trial operations across multiple regions. /p /lipbSupervisory Responsibilities: /b /plipNot Applicable /p /lipbComputer Skills: /b All basic Microsoft Office Programs /ppbOther Qualifications: /b /plip+7 years of experience in GCP-related Quality Assurance function of the pharmaceutical, biotechnology or related health care industry. /p /lilipHigh level of understanding of international GCP requirements and standards in the pharmaceutical, medical device and biotech industries. /p /lilipExcellent English language skills, and additional language depending on locations and need. /p /lilipExcellent verbal and written communication skills /p /lilipAbility to effectively collaborate in a dynamic environment. /p /lipbTravel: /b /plipFlexible to travel, including international. /p /lilipMay require up to 35% travel, sometimes with short notice time. /p /lipSalary Range Switzerland: 141,800.00 CHF - 177,300.00 CHF /ppGlobal Competencies /ppWhen 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. /pliFosters Teamwork /liliProvides and Solicits Honest and Actionable Feedback /liliSelf-Awareness /liliActs Inclusively /liliDemonstrates Initiative /liliEntrepreneurial Mindset /liliContinuous Learning /liliEmbraces Change /liliResults-Oriented /liliAnalytical Thinking/Data Analysis /liliFinancial Excellence /liliCommunicates with Clarity /li