Senior Manager, Global Regulatory Process and Compliance

🕒 vor 1 Monat

🇺🇸 Vereinigte Staaten – Remote

💵 $139.800 - $184.800 / Jahr

⏰ Vollzeit

🟠 Senior

🚔 Compliance

👻 Geisterscore 0%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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BeOne Medicines

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 2010

🧬 Biotechnologie

🏥 Gesundheitswesen

💊 Pharmazie

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines ist ein globales Onkologieunternehmen mit Sitz in der Schweiz, das innovative Therapien entdeckt und entwickelt, die für Krebspatientinnen und -patienten weltweit erschwinglicher und besser zugänglich sind. Mit einem Portfolio, das Hämatologie und solide Tumoren abdeckt, beschleunigt BeOne die Entwicklung seiner vielfältigen Pipeline neuartiger Therapeutika durch interne Kompetenzen und Kooperationen. Mit einem globalen Team von mehr als 11.000 Mitarbeitenden auf sechs Kontinenten setzt sich das Unternehmen dafür ein, den Zugang zu Arzneimitteln für deutlich mehr Patientinnen und Patienten, die sie benötigen, grundlegend zu verbessern.

Beschreibung

• Lead regulatory compliance programs that strengthen GRA’s compliance health, inspection readiness, regulatory information management, and proactive regulatory risk management • Independently assess compliance risks and trends, develop risk-based recommendations, and lead cross-functional initiatives through implementation and effectiveness monitoring • Partner with Global Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical, CMC, Regulatory Operations, and Regulatory Technology • Provide oversight of Veeva RIM data stewardship and regulatory information quality • Monitor data quality and drive resolution of systemic information and process risks • Lead GRA readiness for audits and health authority inspections, including readiness assessments, SME preparation, audit/inspection support, post-audit assessments, trend analysis, and remediation oversight • Conduct GRA compliance risk assessments and maintain the compliance risk portfolio • Assess regulatory changes, health authority expectations, audit/inspection outcomes, and internal compliance issues for GRA impact • Provide compliance guidance and challenge practices creating regulatory or inspection-readiness risk • Monitor critical GRA processes, establish KPIs, thresholds, and escalation triggers, investigate recurring issues, and recommend corrective actions • Partner with Business Process Owners and SMEs to implement actions, assign ownership, track completion, and confirm effectiveness • Develop compliance KPIs, risk indicators, dashboards, escalation thresholds, and management reporting • Combine compliance data to identify recurring and emerging risks and report compliance health, risks, actions, owners, and status to GRA leadership and the Regulatory Compliance Network • Lead root-cause analysis and problem-solving for significant or recurring compliance issues • Develop practical guidance, tools, training, and lessons learned • Build compliance requirements into day-to-day processes and reinforce business ownership • Work independently, lead cross-functional initiatives, hold action owners accountable, and communicate risks and recommendations to senior leadership • May manage direct reports or contractors and provide mentorship, coaching, and guidance

🎯 Anforderungen

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Quality, Technology, or related discipline; advanced degree preferred • 7+ years of progressive experience in Regulatory Affairs, regulatory compliance, Quality, Regulatory Operations, or another GxP function within the pharmaceutical/biotechnology industry • Demonstrated experience independently leading compliance programs, risk assessments, audits/inspection readiness activities, remediation, and cross-functional improvement initiatives • Strong working knowledge of FDA, EMA, MHRA, PMDA and other global health authority expectations, ICH guidelines, applicable GxP requirements, 21 CFR Part 11, and ALCOA+ data integrity principles • Experience supporting or leading health authority inspections and internal audits • Demonstrated ability to perform root-cause analysis, compliance risk assessment, trend analysis, and effectiveness monitoring • Experience with Veeva Vault RIM/BRIM or comparable Regulatory Information Management platforms strongly preferred • Experience developing compliance KPIs, dashboards, trend analyses, and executive-level reporting • Strong analytical and problem-solving capabilities with demonstrated ability to translate data into actionable compliance recommendations • Strong project/program leadership, stakeholder management, facilitation, and organizational change capabilities • Ability to work independently, manage competing priorities, and exercise sound judgment in a complex global environment • Proficiency with regulatory information management systems such as Veeva RIM and electronic document management systems • Experience with compliance monitoring dashboards, data analytics, and reporting tools such as Power BI, Tableau, or equivalent • Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, SharePoint, Outlook, Teams) • RAC, ASQ CQA, Six Sigma/Lean, project management, or comparable certification preferred • Travel: < 15%

🏖️ Vorteile

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Voluntary participation in the Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness