Global Head, Devices and Combination Products Quality

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The purpose of this position is to set the Vision, establish the Architecture, Catalyze and Coach the global Device Quality community at Roche/Genentech to deliver the Pharma aspiration of 3-5x more medical advances for patients at half the cost to society. Devices and Combination Products will play an increasingly important role in patient centric differentiation. Therefore the purpose of this position is to ensure that the full potential of new and emerging technologies are developed, filed, approved and maintained according to current global quality standards. This position will lead the Development (IMP) and Commercial device quality network in a flexible and agile manner, including evolving the position and quality community to meet the future needs of the business. This position is part of the Global IMP Quality community, and is expected to shape and deliver the IMPQ strategy, including Right First Time Process Qualification and Real-time quality decision making. The position is also part of the broader PTQ Device Quality Community, and is expected to collaborate effectively across the organization to ensure reliable end to end delivery, and to evolve the organization to be more agile and effective. This position will coach and catalyse the global team to ensure that device and combination product (CP) development activities and decisions are in compliance with the cGMP regulations for Combination Products, Medical Device Regulation, and Roche standards. This position will collaborate across the CP community to ensure robust, patient centric and timely CP design, filing, and approval. This leader will bring a high level of engagement to the development of CP Quality and Risk Management Plans. Job Responsibilities: Coach the team to unleash the full potential of every member, including agile and innovative approaches to capability building and self management. Ensure an environment that fosters deep inclusion, and leverages the full spectrum of diversity. Ensure all products are developed, filed, approved and maintained according to global HA requirements and Roche standards. Review dossiers and ensure robust regulatory filings. Influence global HA requirements through presentation, publications and feedback on emerging guidance. Provide strategic guidance to evolve Roche quality standards according to emerging HA guidance. Work across the Roche Device and CP community to evolve this position and the organization to better meet the Pharma Vision going forward. Establish and maintain a functional budget with a high sense of fiduciary responsibility. Assure the creation of device design control documentation, risk management plans and reports, and effective corrective and preventative actions to reduce risk and improve reliability. Coach team to provide consistent design assurance during CP development to ensure compliance with the Quality Systems Regulations, Medical Device Regulation and Roche/Genentech standards for combination product development. Provide opinions and interpretation of CP cGMPs to Quality and Device Development. Share CP quality knowledge with Device Development based on thorough knowledge of global regulations. Partner with peers to ensure that knowledge and understanding of CP quality requirements is continuously improved. Present at meetings, conferences, workshops and industry benchmarking activities and serves as Roche representative for CP quality. Participate as part of governance teams, ensuring establishment of quality goals/metrics and monitor progress. Notify Management of potential or realized issues that may affect product quality or regulatory compliance. Provide quality management oversight for design transfer, product transfers, new technologies, and commercial products produced in the internal network or at CMOs, including risk assessments and device design control activities. Collaborate to provide Global Quality Oversight of Medical Device Suppliers and Device Service Providers throughout the lifecycle. Support the timely resolution of investigations and quality issues including complaints to support release of finished clinical and commercial CPs. Represent department at Quality Review Board and Change Review Board meetings. Recommend and implement improvements to Quality operational policies, plans and procedures. Act as an integral member of process improvement teams and process rollouts. Support regulatory inspections, Roche/Genentech compliance audits and regulatory filings (i.e., review and provide input to filing documentation). Job Requirements/Qualifications: Visionary: Able to create a compelling vision that inspires the organization to achieve outstanding results and enable the Pharma aspirations. Architect: Evolve the systems and organization to meet the future needs of the patient, business and global Health Authorities (HAs). Coach: Enable every team member to offer their full potential, including agile and innovative approaches to capability building and self management. Catalyst: Clear road-blocks, and get directly involved, across boundaries and in a collaborative and timely way to make it happen. A high degree of self awareness A strong value of diversity, and the ability to create an inclusive environment on a global scale. A continuous learner who actively builds their own and others’ capabilities. An agile and collaborative mindset, able to develop high performing teams regardless of organizational boundaries. Able to lead/collaborate effectively in a matrixed and distributed environment. Able to build partnerships between companies. Demonstrated ability to influence quality mind-set, strategy and processes. In depth experience in development, implementation and management of CP quality systems; including CP life cycle management. Demonstrated capability to apply expertise in day-to-day activities and problem solving. Demonstrated analytical decision making capability and strong track record of soliciting input and applying sound judgment to make timely, fact-based decisions. B.A. or BS degree in a scientific discipline, graduate degree preferred and 12- 15 years relevant experience in the development and commercialization of drug delivery devices, design for manufacture and assembly including 7 years of supervisory experience. Demonstrated expert knowledge of Design Controls, ISO13485, 21CFR820, ISO14971, and MDR. Knowledge of emerging technologies and regulations. Able to foster innovation. Demonstrated capability of applying advanced risk management concepts and tools. Well developed interpersonal skills with the ability to communicate clearly and professionally both in writing and verbally Quality Engineer certification (ASQ) recommended. Ability to travel domestically and internationally.

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