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职位
The GxP Supplier Management Chapter Lead has regional responsibility, together
with other Chapter Leads, for Quality and Compliance of manufacturing performed
by third parties forPharma Global Technical Operations (PT), including quality
oversight, inspection readiness, and operational product quality management.
This is a unique and exciting opportunity to empower, coach and inspire
people! You have the ability to foster an environment where people feel
included and safe to learn through experimentation, contribute their value
autonomously and challenge the status quo. You enable Chapter Members to be the
best version of themselves during the organization’s cultural evolution journey.
This position reports directly to the Head of External Quality and as part of
the External Quality Enabling Team plays a key role in shaping and implementing
GxP Supplier Management strategies that are aligned with the External Quality
strategy and overall company vision.
This role requires a leader who is entrepreneurial and strategic, comfortable
with both hands-on executional work and big picture thinking. The GxP Supplier
Management Chapter Lead acts as a strategic partner to key internal and
external stakeholders in support of a wide range of organizational priorities
and business needs.
Key Responsibilities
* Lead an empowered team of approximately 15-20 Chapter Members with a wide
range of expertise (coming from multidisciplinary functions) to ensure “Right
to Operate” by implementing a customer-orientated lean end-to-end mindset.
* Responsibilities extend to oversight of external parties involved in the
supply chain of Roche products. Chapters are responsible for ensuring GMP
compliance in accordance with cGMP, Roche corporate standards and the
requirements of applicable health authorities and other regulatory agencies.
* Ensures timely and thorough identification and communication of any GMP
compliance gaps or risks across external operations.
* Responsible for monitoring material and device quality, deploying resources
to partner with suppliers and sites to improve process capability continuous
improvement.
* Deliver successful execution and realization of Technical Transfer and
Product Launch projects to enable network strategy.
* Accountable for establishing and conducting Quality Governance within
External Quality (e.g. Quality Council, Quality System Management Reviews
(QSMR) Quality Review Board (QRB), Management Review of Quality (MROQ), etc.
* Collaborate with other Chapter Leads, Squad Leads and Stakeholders to meet
and adapt to both current and future needs of the Chapter and organization
(skills, capabilities, technologies, etc.), co-create and embed the long-term
External Quality vision and strategy.
* Develop roadmap to drive efficiency and effectiveness through continuous
improvement and the establishment of harmonized/standardized systems, processes
and tools.
* Represents Roche/External Quality at business reviews to drive consistent
performance and higher customer satisfaction, negotiating with senior
management, both internally and externally, to influence decisions.
* Responsible for delivery of quality products from Suppliers on time in full
(i.e. MAR activities).
* Coach team members to drive resolution of deviations and issues and to
ensure CMOs and other relevant external partners/alliances achieve and maintain
a consistent state of full compliance and inspection-readiness.
* Responsible for the team’s personal and professional development, driving
an agile mindset and demonstrating visionary, architect, catalyst and coach
(VACC) leadership behaviors.
* Enable talent flow in order to meet the business needs
* Accountable for co-creating strategies to optimize budget and spending,
including monitoring spending patterns and implementing measures to promote
adherence to budgets
* Looks beyond area of responsibility to define and resolve complex,
operational and organizational problems leveraging resources within or outside
department with E2E product view
* Quality decision maker in GEG for suppliers and other cross-functional
governance meetings as deputy of Head External Quality
* Sponsor/chair external supplier issue management process and system,
including escalation to management of potential major quality