Clinical Demand and Supply Leader (m/w/d) - cGMP/ SAP/clinical trial / cGCP/ English /Deutsch
For our client a big pharmaceutical company in Kaiseraugst we are looking for a Clinical Demand and Supply Leader (m/w/d)
Behind every presentation of each product sold by the company is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than employees worldwide.
"Global Technical Development" (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, we actively collaborate and develop creative technical solutions to bridge early-stage, late-stage and commercial product needs. The mandate of the group is, to expertly deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication, and mutual respect and contributes every single day, continuously improving what it does.
The Clinical Supply Chain Management (PTDS) organization's mission is to ensure that the right product is in the right place at the right time every time, such that no patient will go without and no clinical trial will be delayed.
The Clinical Demand & Supply Planning organization's mission is to cost-effectively ensure the right product is in the right place at the right time every time, such that no patient will go without treatment and no clinical trial will be delayed.
The Clinical Demand & Supply Leader (CDSL) is a supply chain owner assigned at the molecule level to ensure timely and adequately drug product manufacturing and patient kit packaging for the entire portfolio of clinical trials by aligning activities with Technical Development Team (TDT) and Clinical Operations project milestones.
Tasks & Responsibilities:
* Ensure the effective and efficient set-up of the clinical supply chain and the delivery of study supplies in accordance with international standards and regulatory requirements
. Translate clinical trial assumptions into drug forecasts and associated supply/distribution plans, initiates required activities & supply execution processes, and maintains oversight of the production, release, and distribution steps necessary to maintain a continuous supply of drug from FPI through completion of the clinical trial
. Matrix leader of a team including packaging logistics & operations, label design, and distribution experts to ensure timely and compliant patient kit design, packaging, labeling as well as sufficient stocks of medication at depots of the Roche IMP (Investigational Medicinal Products) distribution network
. Member of the TDT and acts as the liaison between TDT and Clinical Operations study teams and you are the primary PTDS interface to our Clinical Operations customers, and is the contact for all strategic clinical supply related issues
. Customer oriented single point of contact for all individually owned clinical supply projects and will represent the function in cross-functional and multi-national teams
. Take ownership over various Clinical Supply Chain business processes and/or related systems; leading cross-functional teams as required driving business improvement, influencing change, and ensuring global process integration
. You have an academic degree or equivalent diploma preferred in life sciences and you bring minimum 5 years' work experience in the pharmaceutical industry or equivalent supply chain functions.
. Clinical and/or drug development experience and knowledge in cGMPs, cGCPs and EU Clinical Trial Directive with experience in project management in a cross-functional and cross-cultural environment
. Sound knowledge of Microsoft Office and SAP/APO is required
. Excellent written/oral communication in German and English
* Ability to work independently with limited supervision.
. Self-motivated, proactive, quick thinking and adaptable.
. Ability to set priorities and to remain flexible in stressful situations
. Customer-focused, ability to create trustful relationships with business partners as well as excellent problem solving and analytical skills
* 08:00am - 12:00am and 13:00pm - 17:00pm (flexible working times)
Referenz Nr.: 919825SGR
Rolle: Clinical Demand and Supply Leader
Industrie: Pharma ~
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert.