Associate Director, Product Quality Steward

Das ist der Job

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

Darum lohnt es sich

Ensure comprehensive root cause analysis for investigations, OOS and other events drives effective CAPA plans. /ppThis individual will collaborate across functions and sites to drive continuous improvement, ensure regulatory compliance, and build a robust knowledge-sharing and risk management culture. /pulliRepresent the Quality Organization at platform level through participation in molecule level governance meetings and forums. /liliServe as a Subject Matter Expert (SME) and Facilitator for quality risk assessment, investigations, change control, and resolution of complex quality issues including review of regulatory CMC submission content /liliManage Product Quality Network teams responsible for deliverables for multiple late-phase clinical or commercial programs /liliCollaborate with RD, manufacturing (CMC) and regulatory teams to ensure quality considerations are embedded in new product development and lifecycle management. /liliAdvise and influence CMC strategies leveraging quality risk management (ICHQ9) for commercialization including strategies for in process controls, specifications, stability, and comparability /liliContribute to product quality performance monitoring, identifying trends and driving improvements. /liliLead or participate in cross-functional teams to improve quality systems and address systemic challenges. /liliSupport regulatory inspections and audits, ensuring alignment with global quality standards and best practices. /liliPerform other related responsibilities as assigned. /li /ulh3Supervisory Responsibilities /h3ulli5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources. /li /ulh3Education Required /h3ulliBachelor's degree and 6+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices). /liliMaster's degree and 8+ years experience preferred /li /ulh3Computer Skills /h3ulliStrong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). /liliExperience in statistical modeling software (Mintab, JMP, Tableau, SciLab /li /ulh3Other Qualifications /h3ulliAdvanced degree in life sciences, quality management, or related field /liliExtensive experience in leading quality investigations, quality risk management, and implementing new technologies. /liliExpertise in quality systems, regulatory requirements (e.g., FDA, EMA), and risk management frameworks (e.g., ICH Q9). /liliStrong leadership and problem-solving skills, with the ability to manage complexity and ambiguity. /liliExperience in developing and delivering global training programs ad fostering SME networks. /liliProficiency in quality tools and methodologies (e.g., root cause analysis, Lean, Six Sigma). /liliAbility to communicate complex information clearly and effectively across business functions /li /ulpTravel: Up to 20% /ppSalary Range Switzerland: 148,900.00 CHF - 186,100.00 CHF /ph3Global Competencies /h3ulliFosters 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 /ulpWe are proud to be an equal opportunity employer.

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. /ppThe Product Quality Steward (PQS), as part of the Quality Sciences and Knowledge Management organization, will play a critical role in advancing global quality initiatives and manufacturing strategies ensuring the highest standards of product quality and fostering expertise in emerging quality technologies.

This position will actively contribute to quality improvement through execution of core QMS product governance tools including change management, APQR and Issue Escalation/Notice to Management.

The Product Steward will actively analyze product data trends such that proactive compliance is maintained for BeOne's patients. /ppThe PQS will support cross-functional collaboration, drive process improvements and enhance the organization's approach to quality governance through the entire product lifecycle.

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 /p