Quality Governance Lead
Roche
At Roche, we are passionate about transforming healthcare and changing patients lives. As a global leader in pharmaceuticals and diagnostics, we focus on driving scientific excellence and delivering innovative solutions that address some of the world’s most complex medical challenges. We believe that doing now what patients need next requires a diverse, inclusive, and collaborative environment where every individual is empowered to contribute to our shared purpose. Quality is at the heart of everything we do, ensuring that our life-saving treatments meet the highest standards of safety, efficacy, and compliance across the globe.
The Oppurtunity
- Drive Governance Strategy: Define and execute the global MRoQ governance strategy, ensuring full alignment with enterprise quality objectives, business priorities, and global regulatory expectations.
- Orchestrate Global Review Cycles: Lead the end-to-end planning, coordination, and execution of global MRoQ cycles across diverse sectors, including Internal/External Manufacturing, Investigational Medicinal Products (IMP), and Cell & Gene Therapy.
- Facilitate Senior Decision-Making: Enable leadership and key decision-making forums by synthesizing complex quality performance data into high-quality, data-driven materials and executive-level insights.
- Standardize Frameworks and Tools: Establish, maintain, and continuously improve standardized MRoQ frameworks, templates, and digital tools to enable scalable, efficient, and consistent execution across the network.
- Manage Forum Outputs: Orchestrate governance review forums to ensure clear, documented outcomes, and establish robust systems for tracking accountability, actions, and risk-mitigation commitments.
- Foster Collaboration & Community: Build and lead a highly connected, cross-functional MRoQ governance community that champions transparency, process harmonization, and a strong culture of quality.
- Support Inspection Readiness: Act as a key delegate for MRoQ and quality governance responsibilities, providing vital support and presentation-ready documentation during regulatory inspections and internal audits.
Who you are:
- Educational Background: You possess a Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related scientific discipline.
- Industry Experience: You bring 7 years++ of dedicated experience in a Quality (GxP) environment, with specific expertise in Quality Governance, QA, or Compliance within the pharmaceutical or biotech industry.
- Regulatory & Domain Knowledge: You maintain a strong working knowledge of GMP, GCP, and/or GDP regulations across multiple domains, such as clinical supply or commercial manufacturing.
- Governance Expertise: You have hands‑on experience supporting, coordinating, or facilitating management reviews, quality council forums, or complex multi‑tiered corporate governance processes.
- Analytical & Communication Capability: You are skilled at analyzing complex quality data and translating these insights into clear, actionable executive reporting and strategic messages.
- Stakeholder & Matrix Collaboration: You excel at partnering cross‑functionally and managing stakeholders across global sites, functions, and leadership levels to drive organizational alignment.
- Project Management & Leadership: You possess solid project management skills, an aptitude for driving continuous improvement, and emerging leadership capabilities such as mentoring teams or leading complex workstreams.
Required Skills
Relocation benefits not available for this position
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