Here is a refined version of the job description with improved formatting and clarity:
Global Clinical Supply Chain cGMP Compliance Manager, Kaiseraugst
Department: Business Operations Support (PTDS-R)
The Global Clinical Supply Chain (GCSC) organization’s objective is to ensure the right product is in the right place at the right time, cost-effectively, so that no patient goes without treatment and no clinical trial is delayed.
The Business Operations Support (BOS) team, with members based in Kaiseraugst (CH), South San Francisco (US), and Mississauga (CA), supports all clinical supply chain functions with expertise in Strategy, Business Excellence, Business Analytics, and Learning & Engagement. BOS focuses on strategy review, project management, goal setting, risk management, process management, master data, analytics, reporting, resource planning, training, communication, and LEAN methodologies.
The newly created cGMP Compliance Manager role will focus on Quality compliance, acting as a central compliance center of excellence, and collaborating closely with all GCSC functions (Plan, Source, Make, Deliver, Enable). Collaboration with compliance experts in Pharma Technical Operations Development (PTD) and Quality (PTQ and PDQ) will be essential.
Your responsibilities
* Maintain and improve compliance of the Global Clinical Supply Chain with Roche PQS, GxP, and Health Authority requirements for sourcing, manufacturing, and distribution of IMPs. Participate as a business member on the Compliance Quality Council.
* Contribute to the BOS team by creating a compliance vision and long-term development roadmap for PTDS areas.
* Design effective collaboration models within PTDS and other functions to ensure governance, execution, and analysis processes are compliant.
* Establish an expertise center for supply chain quality compliance topics, promoting understanding, adherence, and monitoring across PTDS, and lead community initiatives as needed.
* Provide coaching to quality compliance experts to enhance knowledge and capabilities.
* Anticipate changes in compliance frameworks and assess their implications for training, processes, documentation, systems, and data.
* Facilitate annual compliance goal setting, tracking, reporting, and transparency of KPI progress.
* Prepare for and participate in audits and inspections; lead quality compliance improvement projects and cross-functional governance activities.
* Act as deputy for Risk Management and Business Continuity within BOS.
Who you are
* Bachelor’s degree in Life Sciences, Business (Operations or Supply Chain Management), MBA, or higher.
* 7+ years in quality compliance, with supply chain compliance experience advantageous.
* 5+ years in the pharmaceutical industry, with a good understanding of supply chain management; clinical supply chain experience is a plus.
* Fluent in English and German.
* Willingness to travel approximately 10% internationally.
* Proven leadership in matrix organizations, project management, or community leadership, with success in leading cross-functional and cross-cultural teams.
* Strong problem-solving skills with proactive approach to issues and solutions.
* Excellent change management and communication skills, capable of influencing colleagues and decision-makers positively.
* Ability to establish and improve business processes.
* Self-motivated, capable of leading teams, negotiating, and building consensus.
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