- Evaluate, design, optimize & implement the DPI Procedural Document (ProcDoc) Strategy in alignment with business objectives
- Partner with critical quality & business representatives to drive the newly Quality Management System (QMS) module, more specifically Procedural Document Management System
- Partner with Process Owners to design & implement well-defined process, ensuring integration of people, process and system components in business critical ProcDocs
- In collaboration with the business representatives, contribute to cross-functional process
development & improvement initiatives - Act as a change agent supporting compliance and continuous improvement of critical business processes
- Evaluate, design, optimize, implement the DPI Training & Learning Strategy and System in alignment with business objectives
- Partner with critical quality & business representatives to drive the set up and implementation of the newly QMS module, more specifically Learning Management System
- Establish and drive an effective role-specific learning and development structure and "just in time knowledge management" to enable the desired business results
- Partner with Department Heads to ensure fit-for-purpose role-based training curricula are in place
- Identify, evaluate, assess, and select external training vendors ensuring effective availability of effective training programs on specific topics
- Act as a change agent supporting compliance and continuous improvement of DPI training activities in view of on-boarding and continuous learning.
- Work with the Quality Leads to create and execute on engaging eLearning, instructor-led learning, virtual instructor-led learning based on experience from audit, inspection, CAPA and other sources
- Ensure proper CAPA & KPI are developed and monitored
- Training / Learning management
- Master's degree in a scientific discipline or equivalent combination of education and experience
- Preferably 15 years' experience in the Pharmaceutical or Biotechnology industry with a solid experience of at least 8-10 years in QMS in a GxP environment
- Solid experience and expertise in design, harmonization, implementation, and optimization of cross-functional end-to-end business processes
- Six Sigma certification/operational excellence and/or experience with process mapping tools and systems is desirable
- Experience in understanding global regulatory GxP requirements and industry trends with the ability to apply them to process improvement
- Experience in supporting Regulatory Inspection and Due Diligence activities
- Significant experience with QMS tools, more specifically Procedural
Document Management System and Learning Management System - Functional planning experience & ability to develop functional vision, priorities and tactics
- Strong leadership, pragmatic collaboration and influencing skills in a complex, matrix environment
- Experience in mentoring, coaching and directing people to ensure proper implementation of the management endorsed strategy
- Strong team player, with excellent interpersonal communication skills
- Used to simultaneously support multiple projects, duties and assignments and prioritize accordingly
- Self-dependent way of working; taking ownership of assigned tasks; plan and deliver according to agreed timelines
- Proficiency in English (C1 Oral & written), fluent French is an asset
- International, highly dynamic environment with a long term vision.
- Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
- Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
- Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.
- Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities
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P2325 - Global (Senior) Manager, Procedural Document & Training Quality Lead - Lausanne, Schweiz - Debiopharm
Beschreibung
Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique "development only" business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.
At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.
Here:
For our Quality Management organization based at our Headquarters in Lausanne, we are looking for a
Global (Senior) Manager, Procedural Document & Training Quality Lead
In this role, you will drive the overall management of Procedural Document Management and Training Management activities throughout the Debiopharm International SA (DPI) organization. You will build a collaborative working relationship & partner with the business partners and cross-functional Quality Peers. This role requires active participation to Regulatory Authority Inspections & Due Diligence Activities.
Your responsibilities will be but not limited to:
Procedural Document Management
Requirements
Benefits
Debiopharm offers employees:
The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.
Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.
Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.
