Job Description

The Position Who We Are At Roche, we are passionate about transforming patients\' lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. Role Purpose As the Roche Information Solutions (RIS) Process Excellence and Quality Management Systems (QMS) Sub-Chapter Lead , you will be a member of the RIS Quality & Regulatory (Q&R) Team. In this position, you will be the local leading figure and key point of contact for Roche Diagnostics\' capabilities in Process Excellence and Quality Systems for RIS Pune (India). You are accountable for the Quality Management System (QMS) and ensuring compliance with applicable and regional regulatory requirements this includes activities associated with QMS Operations, QMS Strategy and Governance, and Documented Information. You will improve the sub-chapter\'s overarching expertise based on current and upcoming needs to deliver on network priorities (e.g., upcoming portfolio investments with new technology skills needed). You will be responsible to excel in developing the capabilities of Sub-Chapter members specialized in Quality Systems including their skills in management of digital products, processes, audit expertise, establishment registrations and certifications. As a line manager of Sub-Chapter members, you will be responsible for designing and optimizing Sub-Chapter members\' personal professional journey, coaching, and liaising with other Quality & Regulatory operations In your work with Sub-Chapter members, you\'ll apply Vision, Architecture, Coach and Catalyst (VACC) principles to encourage: A mindset of creativity and experimentation to enable RIS Q&R to be a true trailblazer that supports radical simplification and continuous innovation People leaders to empower staff and delegate decision making to those closest to the work Individual contributors to proactively seek advice to develop the most creative and innovative global registration and submission strategies Advocating inclusion of innovative approaches within projects that help advance our objectives Ongoing knowledge sharing of quality and project topics related to systems and software Self-directed career development Radically simplifying, and focusing on the most impactful work to advance the customer needs Standardizing processes, leveraging systems and tools, and valuing data as an asset You will partner with the Function and Network Leads within RIS. These interactions are intended to support bringing the right capabilities and expertise to the efforts to deliver across the Networks\' priorities (who organize around business value). You will play a key role in crafting and implementing key aspects of RIS Q&R\'s mid- to long-term strategy and ultimately contribute to the overall Roche Diagnostics Vision. You will be responsible for... Leading and managing the Quality Systems function in the Roche Pune region. Driving the compliance activities required by Global Health Authorities including the US FDA, China NMPA, and EU Competent Authorities as well as worldwide regulatory requirements and quality system standards required for In-Vitro Diagnostics and Medical Device Manufactures to assure a sustainable state of compliance. Interfacing with senior leadership from Global Operations, Quality Management, Software Development, and other key decision makers to assure all products and processes are managed in accordance with applicable international standards and regulations, company standards, and quality systems. This is accomplished through Strategic Quality Planning, Quality System execution and maintenance, continuous improvement, integration, harmonization, and the use of performance metrics and Quality Systems technology advancements. Translating the overall vision and values to the team establishing mid- to long-term objectives to align with the company vision and accomplish organizational goals. Determining and implementing the best strategic direction for the Quality Systems function with regard to organization, competencies, human and fiscal resource planning, quality planning and Quality Systems best practices. Coaching and delegating to Quality Systems staff in activities including but not limited to: Strategic Quality Planning, Regulation Monitoring, QMS integration/ harmonization/improvement activities, Management Review, Data Analytics, Quality System IT Tool technology management, External Inspection Management, and Change Management. Taking ideas from concept to project to full implementation establishing new or interpreting and recommending modifications to existing company policies or procedures. Representing the organization as a subject matter expert with Regulatory agencies and professional organizations to ensure the Quality Management System remains current and competitive. Being knowledgeable of external trends and driving external views internally as appropriate. Participating in regional or global cross-functional meetings/initiatives and setting and maintaining the standards for interdepartmental actions and the integration of quality planning with development and operations planning. Performing administrative functions for junior and senior Quality professionals including performance management, goal and objective setting, and personal development planning. Assuring short term training needs for staff are addressed, and longer term individual and organizational development needs are identified, planned, and implemented. Managing external resources, including consultants. Developing and managing the budget ensuring goals, deadlines, and budgets are met. Operating independently and highly autonomously, holding yourself accountable to proactively fulfill tasks and achieve results within assigned timelines. Providing solutions to highly complex, significant, and complex issues developing solutions based on in-depth technical knowledge, company policies, or defined process paths. Understanding strategic priorities developed by executive management responding to requests with appropriate urgency and with an organized approach. As the Sub-Chapter Lead you: Are committed to cross-functional collaboration and breaking down silos to achieve the best results for the organization. Have the ability to navigate within a changing organization, maintaining objectivity, respect for differences of opinion, fairness, open communication and consensus building skills. What else do you have in your toolbox: Bachelors\' degree in Biological Sciences, Quality Engineering or related field, or equivalent combination of education and work experience. Master\'s degree/PhD, or equivalent preferred. ASQ Certified Quality Manager (CQM), Engineer (CQE), Auditor (CQA) preferred. 8+ years minimum (10+ preferred) of relevant medical diagnostic/device industry experience, including experience focused on quality systems, regulatory affairs/compliance, project management, controlled documentation, quality data analytics, and change control. Thorough working knowledge of relevant international ISO Standards (ISO 13485, 14971) and regulations (MDR, IVDR, 21 CFR - part 820). Direct experience working in a US FDA regulated environment preferred. Experience with the Medical Device Single Audit Program (MDSAP) preferred. Experience in Agile Software Development and Quality Management Systems adapted to enable the application of Agile in medical device software development. Enthusiasm for the role that Quality and Regulatory (Q&R) can play in enabling the development and manufacture of products for our patients. Drive to engage positively with Q&R/Business teams and make impactful contributions in a multicultural/national environment. Track record of providing sound Q&R judgment/ideas, critical decision-making, effective people management, and business partnering. Superior leadership/interpersonal/integrating/problem-solving skills and demonstrated ability to collaborate effectively across a variety of workgroups in demanding/changing situations (medical, scientific, and manufacturing). Strong communication and presentation skills, with ability to get points across clearly and simply Leadership The successful candidate will build and provide effective leadership for the team in a manner that is consistent with the Roche Values and leadership capabilities. They will seek to inspire and lead their team to create transformative solutions that will ensure that Information Solutions are recognized as being the best in the industry and maintains our #1 ranking in the future. Everything you do should contribute directly to the achievement of our Roche Ten Year ambitions, including: Double patient access to novel, high-medical-value diagnostics solutions Build the leading, profitable insights business Improve patients\' lives via \'OneRoche Approach\' to ecosystem in every country Mindset We@RocheDiagnostics is the mindset and culture we as Diagnostics colleagues strive to adopt to help achieve our vision and realize our strategy. The We@RocheDiagnostics dimensions are: We are passionate about our customers and patients We radically simplify We trust, collaborate & have fun We ALL lead We experiment & learn You are expected to demonstrate the We@RocheDiagnostics dimensions and help evolve the functions culture beliefs, beginning it to life as part of the Diagnostics Transformation. Locations You can be based in Pune, India, or a major Roche site. At the Company\'s discretion, an exception to the location requirement could be made under extraordinary circumstances. As this position is a global role, international business travel will be required depending upon the business location of the successful candidate and ongoing business project activities. Roche is strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients. Roche is an equal opportunity employer. . Additional details regarding this role: - The Subchapter Lead will be responsible for establishing the global, modular QMS at the Pune site in alignment with global Q&R strategic priorities. - The Subchapter Lead will be primarily responsible for leading the following core activities: Global QMS Governance and Strategy, including process excellence and change management (for global QMS and network process changes), notified body and certification management, and Quality Manual ownership Audit and Inspection Management, including inspection readiness, planning and coordination with health authorities and notified bodies, audit/inspection hosting, and audit/inspection response management Management Review, including administration of proactive quality system reviews, quality planning, quality objective setting, and management of quality metrics Nonconformance and CAPA Management, including program oversight, partnering and approvals, root cause analysis, and tracking/analytics/visualization of NC and CAPA metrics Quality review and approval of QMS procedures and documentation related to management of the QMS Quality Agreement Management and Pharma Collaboration Collaboration with global teams responsible for supplier management, training, internal auditing, post-market, and information security and privacy Who we are At 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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