Fusion - Quality Functional Partner

$98,900 - $209,000/Yr

Roche - Tucson, AZ

Full-time - Senior

Tucson, AZ

10,001+ employees

Chemical Manufacturing

About the position

The role of Quality Functional Partner at Roche involves leading the Quality and Regulatory (Q&R) hub, representing the Quality organization in Lifecycle Teams (LCTs), and collaborating with Network Leads to foster proactive quality strategies. This position emphasizes the importance of modeling agile behaviors and contributing to Roche's long-term ambitions. The Quality Functional Partner will focus on strategic initiatives, risk management, and fostering a culture of continuous improvement within the organization. As the Q&R Hub Lead, you will be responsible for achieving alignment on shared priorities, addressing quality issues, and compliance gaps by connecting to critical pre- and post-market issues. You will drive data-based action plans, propose solutions, and provide appropriate support and resolution. Effective communication of critical quality or regulatory issues and risks is essential to ensure transparency and unified messaging across teams. In your role supporting the Lifecycle Team, you will represent the Quality organization in all aspects, partnering to resolve quality issues and ensuring prioritization to meet customer demands. You will serve as the main point of contact for Quality in LCTs, providing guidance and receiving quality-related requests. Collaboration with Quality Function Partners from all Customer Areas will be key to sharing lessons learned and advancing the work of Q&R. You will lead or support strategic initiatives aimed at shifting focus from reactive to proactive quality, fostering an agile mindset, and building strong partnerships to ensure alignment on strategic projects and day-to-day activities. Your role will also involve breaking down silos and improving working effectiveness through collaboration with other Networks, Chapters, and stakeholders. You will promote a culture of continuous improvement, driving solutions and decision-making even without perfect solutions, and lead and support audit and CAPA activities as applicable. This position requires a bachelor's or master's degree with 7-10 years of experience in quality management or quality control, or a PhD with 5-10 years of experience, along with QP qualification according to AMG §15 Approbation as pharmacist if necessary. You should have over 10 years of experience in quality and regulatory roles within the diagnostics industry, with deep knowledge of international laws and regulations for the development and manufacturing of diagnostic products, such as IVDR, QSReg, ISO 13485, NMPA, and MDSAP. Recognized for your thought leadership in quality and regulatory matters, you will have a strong track record in building and nurturing capabilities in quality and compliance knowledge, regulatory expertise, communication, and stakeholder management.

Responsibilities

• Lead the Q&R hub to achieve alignment on shared priorities and address quality issues and compliance gaps.
• Drive data-based action plans and propose solutions to critical quality or regulatory issues.
• Communicate critical quality or regulatory issues and risks to ensure transparency and unified messaging.
• Initiate and lead squads for specific requests, topics, or projects from the Lifecycle Team (LCT) or Customer Areas.
• Represent the Quality organization in all aspects for LCT, partnering to resolve quality issues and ensuring prioritization to meet customer demands.
• Serve as the main point of contact for Quality in LCTs, providing guidance and receiving quality-related requests.
• Collaborate with Quality Function Partners (QFPs) from all Customer Areas to share lessons learned.
• Lead or support strategic initiatives to shift focus from reactive to proactive quality and foster an agile mindset.
• Build and maintain strong partnerships to ensure alignment on strategic projects and day-to-day activities.
• Break down silos and improve working effectiveness through collaboration with other Networks, Chapters, and stakeholders.
• Align with design quality assurance to improve product quality at launch.
• Promote a culture of continuous improvement, driving solutions and decision-making even without perfect solutions.
• Lead and support audit and CAPA activities as applicable.
• Collaborate closely with Product Quality Leads (PQL) to implement data-driven solutions throughout the organization.
• Collaborate and coordinate with Network Leads on areas of concern to bring action and provide visibility.
• Act as a role model for Agile behaviors and support the organization's transformation to new more Agile Ways of Working.

Requirements

• Bachelor's or master's degree with 7-10 years of experience in quality management or quality control, or a PhD with 5-10 years of experience.
• QP qualification according to AMG §15 Approbation as pharmacist if necessary.
• Over 10 years of experience in quality and regulatory roles within the diagnostics industry.
• Deep knowledge of international laws and regulations for the development and manufacturing of diagnostic products, such as IVDR, QSReg, ISO 13485, NMPA, and MDSAP.
• Recognized for thought leadership in quality and regulatory matters.
• Strong track record in building and nurturing capabilities in quality and compliance knowledge, regulatory expertise, communication, and stakeholder management.

Nice-to-haves

• Proven ability to lead with creativity and high self-awareness.
• Ability to build networks and inspire agile working.
• Skill in prioritizing resources and fostering positive partnerships through effective influencing and conflict management.
• Recognized as an expert in your specialized area with broad knowledge of your own function.
• Experience solving unique problems that impact the organization.
• Senior advisory experience to management and leadership of large/cross-functional teams, projects, or initiatives.

Benefits

• Relocation benefits available for this position.
• Discretionary annual bonus based on individual and Company performance.