Associate Director, Product Quality Steward

Be One 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.

The 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 Be One's patients.

The PQS will support cross-functional collaboration, drive process improvements and enhance the organization's approach to quality governance through the entire product lifecycle.

Ensure comprehensive root cause analysis for investigations, OOS and other events drives effective CAPA plans.

This individual will collaborate across functions and sites to drive continuous improvement, ensure regulatory compliance, and build a robust knowledge-sharing and risk management culture.

• Represent the Quality Organization at platform level through participation in molecule level governance meetings and forums.
• Serve 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
• Manage Product Quality Network teams responsible for deliverables for multiple late-phase clinical or commercial programs
• Collaborate with R&D, manufacturing (CMC) and regulatory teams to ensure quality considerations are embedded in new product development and lifecycle management.
• Advise and influence CMC strategies leveraging quality risk management (ICHQ9) for commercialization including strategies for in process controls, specifications, stability, and comparability
• Contribute to product quality performance monitoring, identifying trends and driving improvements.
• Lead or participate in cross-functional teams to improve quality systems and address systemic challenges.
• Support regulatory inspections and audits, ensuring alignment with global quality standards and best practices.
• Perform other related responsibilities as assigned.
• Supervisory Responsibilities
• 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

Education Required

• Bachelor'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).
• Master's degree and 8+ years experience preferred
• Computer Skills
• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, Power Point).
• Experience in statistical modeling software (Mintab, JMP, Tableau, Sci Lab
• Other Qualifications
• Advanced degree in life sciences, quality management, or related field
• Extensive experience in leading quality investigations, quality risk management, and implementing new technologies.
• Expertise in quality systems, regulatory requirements (e. g., FDA, EMA), and risk management frameworks (e. g., ICH Q9).
• Strong leadership and problem-solving skills, with the ability to manage complexity and ambiguity.
• Experience in developing and delivering global training programs ad fostering SME networks.
• Proficiency in quality tools and methodologies (e. g., root cause analysis, Lean, Six Sigma).
• Ability to communicate complex information clearly and effectively across business functions
• Travel: Up to 20%
• Salary Range Switzerland: 148,900.00 CHF - 186,100.00 CHF
• Global Competencies
• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

We are proud to be an equal opportunity employer.

Be One 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.

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