Medical Quality Manager

Job Description

The PositionPurpose of the RoleThe Local Quality Responsible is a strategic partner of the business and the global PD Quality (PDQ) Function, responsible for ensuring that the Affiliate Quality Management System (QMS) and local Medical Compliance related activities are delivered in accordance with the applicable Roche standards, global quality strategy, regulatory requirements and industry best practices.By delivering a healthy Affiliate QMS and applying the below VACC principles and through cross-functional collaborations, the LQR proactively acts in the service of safeguarding patient?s rights, access to innovative healthcare solutions, the reliability of Roche?s data integrity and supporting business priorities.VACC principles

• Visionary: Shaping the Quality vision (internally and externally), by creative leadership, living the Roche Operating Principles, supporting transparency, consistency and co-creation across the organization, promoting the GxP Guardrails and a Quality Culture that ensures the highest standards of Quality and Medical Compliance.
• Architect: Evolves the LQR role/teams and with expertise, empowers Affiliate teams to make decisions, enables actions and networking across organizational boundaries based on business needs, flow, transparency and trust.
• Coach: Helps the affiliate and their network to build the skills and mindset they need to succeed; coaching and being coached, coaching the business on quality, training, audit/ inspection readiness, deviation & risk management based on previous learnings and network expertise.
• Catalyst: Removes obstacles, prioritizing to create synergies, clarity and focus; collaborates internally and externally to solve QMS and Medical Compliance bottlenecks.

Network Enabler

• Act as trusted Quality Partner for the local Enabling Team by actively engaging on strategic decisions, fulfilling the VACC principles, ensuring process and system alignment, driving quality solutions and safeguarding high Quality standards and Medical Compliance.
• Identifies and works in partnership with key local and global stakeholders (e.g PDQ, QCLs) to maintain quality standards and to support continuous improvement in the Affiliate.
• Participate in the Network Entities sharing knowledge, enhance stakeholder collaboration, promote quality and ensure business objectives are met (e.g LQR Network, QNeo, CoPs).
• Provide peer-to-peer knowledge sharing within the Quality network, including buddying new LQRs.

Key AccountabilitiesLead Local QMS and Medical Compliance

• Lead and manage the OneRoche QMS at Affiliate level to meet regulatory requirements, evolving the QMS as the enabler for Roche?s evolving vision and pipeline.
• Supports the implementation in the Affiliate of the global Quality strategy and quality objectives, as appropriate.
• Leads the Affiliate Management Review(MRs) and Local Medical Compliance Office (LMCO) processes ensuring that key outputs are understood by senior management and appropriate actions are taken where necessary.
• Drives and enables the overall QMS Deviation Management process at local affiliate level.

• Ensures that a local training grid containing medical compliance related curriculumsis in place.
• Owns the local QMS controlled document management process and collaborates with SMEs to implement and maintain local procedural documents in line with global processes (QMS document alignment) and local regulatory requirements.
• Ensures that the records management requirements for QMS are established and followed by the Affiliate in accordance with the Roche Global Records Management Directive in collaboration with the respective COREMAP representative.
• Drives and enables the QMS Service Provider oversight process at local level.

Lead Quality Culture and Quality Insights

• Act as Quality Advocate across the organization, promoting the GxP Guardrails and Quality Culture in order to ensure the highest standards of Quality and Medical Compliance.
• Proactively monitors and oversees external regulatory changes affecting affiliate Medical Compliance and QMS in alliance with process owners.
• Enables realization of opportunities by partnering strategically with key stakeholders and Enabling team to embed Quality requirements by design.
• Contribute to network communities; sharing knowledge, enhancing stakeholder collaboration, promoting quality, providing peer-to-peer development and driving quality outcomes (e.g LQR Network, QNeo, CoPs).
• Advice seeking - be a stakeholder in providing advice to stakeholders as part of the advice seeking process.

Lead Local Risk & Opportunity (QMS/ Medical Compliance)

• Lead the Risk & Opportunity Management and escalation process at local level to proactively identify, manage, mitigate and escalate QMS and Medical Compliance risks.
• Drive continuous improvement initiatives in order to advance the overall QMS Health.

Lead Local Quality Checks and Audits/Inspections

• Coordinate Audit and Inspection activities targeted at the Affiliate QMS & support audits/ inspections of other Medical Compliance processes and activities.

• Drives and coordinates Quality Checks at Affiliate level in the areas of QMS and Medical Compliance in order to identify any possible gaps or risks that may exist, to ensure compliance and drive continuous improvement.
• Contribute to Global Quality Assurance Strategy by providing local quality insights.

Other Responsibilities

• Additional responsibilities may be applied as per business needs, Work Packages, and/or as defined in local/global procedures, systems and requirements (e.g Healthcare Solutions, RWE, Medical Devices).

Qualification/ Knowledge and Experiences

• Bachelor Degree in Life Science or equivalent is preferred;
• Strong business acumen with desired expertise in QMS, Medical Compliance, Service Provider Oversight, CAPA and Risk Management;
• Understanding the Quality Principles of ISO 9001 & ISO 31000;
• Experience in working with a cross-functional team and international network;
• Experience/ involvement in Audits (and Health Authority inspections) is preferred.
• Experience working in GxP functions preferred
• Lean Six Sigma Qualification eg yellow/Green Belt/ Black Belt

Skills, Mindsets & Behaviors

• VACC Leadership Skills;
• Strong partnering capabilities (consulting, active listening);
• System thinker, enterprise mindset;
• Excellent stakeholder (internal and external) engagement and effective collaboration skills;
• Familiar with the Agile methodology/tools including innovative and creative thinking;
• Digital Literacy;
• Strong verbal and written communication skills;
• Highly self-motivated and able to lead initiatives with authority;
• Ability to translate strategic objectives into operational goals; Accelerates results through strong focus on Outcomes.

Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we?ve become one of the world?s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche is an Equal Opportunity Employer.

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