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The Position
We advance science so that we all have more time with the people we love.
As SubChapter Lead (d / f / m) in Supply Chain Quality for Handling & Storage, you are accountable for the quality of product as it moves through the Supply Chain Operations Network in line with the Quality Management System to ensure that the business products and services are fit for purpose and meet customer expectations and compliance with applicable and regional regulatory requirements. Quality is a competitive advantage for Roche. It allows us to deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Quality is every patient's right and every employee's responsibility.
The Opportunity
You are responsible for oversight of product disposition activities within the supply chain, ensuring they are executed/aligned per the manufacturer and related processes, including deviation management, IRM change implementation, and related data analytics as the product is in the supply chain network.
You work closely with Supply Chain leadership, Operation Quality, Site Organization, Supplier Quality, and Service Providers to develop strategies and set priorities in order to realize business ambitions and impact to the customer and patient. You will interact closely with the Networks within Operations Quality to determine how to best allocate their members to Squads and teams supporting the distribution of products.
You are responsible for ensuring that our Supply Chain Quality Processes and Procedures meet Health Authority regulations, Notified Body requirements, Company standards, and expectations. You establish and support inspection readiness to ensure successful outcomes. You prepare adequate and timely responses to any inspection observations and implement appropriate and thorough correction as necessary and support Hub Operations site Operations to answer HSD Module questions during Audits.
You provide leadership and guidance to staff, directing Supply Chain Quality functions, and manage performance and development of direct reports to ensure achievement of organizational and departmental goals and a productive environment.
You are responsible for developing and implementing the controls that ensure the supply chain continues to develop and implement best practice that emphasizes defect prevention, improved turnaround times, meets the quality standards required to minimize quality costs, and maximize customer satisfaction whilst ensuring adherence to procedures and processes.
You are responsible for the resolution of quality issues in Inbound and Storage (product dispositions, IRM, etc.) by working with the Supply Chain Hub Production, Product Quality, and Suppliers as necessary to achieve problem resolution from the Supply Chain issues and effectively communicate progress and results to our internal teams.
Who You Are
You have a Bachelor's/Master's degree in Life Science, Pharmacy, or related subject. An advanced degree is considered an advantage.
At least five (5) years in the Medical Device/Pharma/Biopharmaceutical industry with 5 years working in Quality Compliance, Regulatory, and/or Validation preferred or equivalent experience.
You have at least three (3) years of demonstrated people leadership experience or equivalent experience.
You have experience in directing and leading large successful organizations.
You have demonstrated experience and knowledge of Supply Chain Quality and processes.
Excellent knowledge of the European, US, China, and International cGMP regulations and demonstrated ability to adequately interpret and implement quality standards.
Locations
You will be based in Mannheim.
As this position is part of a global organization, international business travel will be required depending upon ongoing business project activities.
Your application
We make it easy! All you need to do is upload your CV in English. Further documents will be requested if required.
We look forward to receiving your application!
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A healthier future drives us to innovate. Together, more than 100,000 employees across the globe are dedicated to advancing science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future together.
With around 8,000 employees, Mannheim is the third largest Roche site in the world. It headquarters the Diabetes Care business unit and the sales organization of diagnostics products and is the hub of the worldwide diagnostics business. From your beginning with Roche, our motivated team will welcome and support you. Numerous opportunities for personal development, flexible work hours, attractive compensation packages, and special family assistance programs are available.
Roche is an Equal Opportunity Employer.
Key Skills