QA Manager for Project/Product Transfer for the GMP/GDP Platform of the CTE

Administration

QA Manager for Project/Product Transfer for the GMP/GDP Platform of the CTE

The Experimental Therapies Center is looking for a QA Manager for project/product transfer for the GMP/GDP platform between 80% and 100%.

The Experimental Therapies Center represents the interface between fundamental research and clinical research. This key platform in the fight against cancer plays a fundamental role in the evolution of therapies offered to patients treated at the CHUV, whose specific objective is to support the development of innovative therapies. Thus, to push the boundaries of therapies currently available to patients, our department places particular emphasis on its translational clinical research, which constitutes the bridge between the laboratory and the patient's bedside.

Do you want to contribute to the success and performance of the CTE? Do you want to be part of a team of competent, motivated specialists who play a key role within our institution?

Then keep reading!

Context

The University Hospital of Vaud (CHUV) is one of the 5 Swiss university hospitals. Thanks to its collaboration with the Faculty of Biology and Medicine of the University of Lausanne and EPFL, CHUV plays a leading role in medical care, medical research, and education.

Our UNIL-CHUV oncology department brings together cancer clinic and research in a spirit of innovation. It includes the medical oncology, radio-oncology, hematology services with the CHUV bone marrow transplantation activity, and the Experimental Therapies Center (CTE). It also integrates the Ludwig Center of the University of Lausanne for cancer research, particularly in the field of immunotherapy.

The medical oncology service of CHUV is currently the largest specialized platform in this field in Switzerland. Its mission is to manage, diagnostically and therapeutically, and ensure the follow-up of adult patients suffering from cancerous diseases and to offer each patient access to optimal personalized treatment, whether in routine practice or within clinical studies, taking into account all innovations and changes in knowledge over time.

Mission

Within this mission, you will be responsible for:

• Leading and managing quality assurance activities (planning, drafting, reviewing, approving, and coordinating if necessary) for projects and products of the CTE GMP platform covering activities of:
• Development (late phase);
• Product transfer;
• Optimization of products in GMP production.
• Identifying the required documentation and any content and quality issues for submission and preparation for GMP compliance according to project schedules
• Reviewing and approving all project/product documentation for quality
• Supporting the preparation of audits and regulatory inspections for activities under your responsibility
• During inspections, acting as the main QA contact for product transfer topics and monitoring associated action plans
• In the absence of the GMP quality manager, ensuring the function of GMP quality manager
• Evaluating, reviewing, and approving Change Controls and deviations in cross-functional collaboration with the relevant experts, ensuring compliance with regulatory requirements
• Ensuring technical adequacy, regulatory compliance, and adherence to best practices within the quality and monitoring office and the GMP platform
• Assisting other members of the quality unit in managing the quality system as needed

Profile

• You hold a PhD in life sciences (e.g., chemistry, pharmacy, biochemistry, molecular biology, biotechnology, biology), a Pharmacy degree, or an equivalent qualification
• Training in immunology is a real asset
• You master EU GMP good manufacturing practices and the GMP PIC/S PE009 guide
• You have solid experience in product development and transfer (process and bioanalytical method development, regulation) in the biotechnology industry as well as in a GMP environment
• You demonstrate good command of English and French (spoken and written)
• You have good command of common computer tools (Microsoft Office)
• You are rigorous, have an analytical mind as well as excellent organizational, writing, and interpersonal skills.

We offer

Becoming a collaborator of the University Hospital of Vaud means benefiting from:

• Top social benefits, 20 days paternity leave, and 4 months maternity leave (with the possibility of an additional month of breastfeeding leave)
• Regular salary progression adapted to responsibilities
• A 13th salary and 25 days of vacation per year
• A right to at least three days of training per year, with access to a varied offer within the CHUV Training Center and partner training centers of the State of Vaud
• Facilitated access to one of the 500 furnished apartments offered in the surrounding neighborhoods for people relocating to Switzerland from abroad
• Social, cultural, and economic benefits offered to members of the H-Oxygène association
• Benefits offered within the mobility plan (discounts on public transport subscriptions, promotion of "Mobility" vehicles, and discounts on the purchase of electric bikes)
• Quality hotel-style company restaurants in each hospital building with preferential rates.

Contact and application submission

Contact for information about the position: Ms. Saïda Sabri, QA Operations Manager at: 079 556 09 39.

Since all our applications are processed electronically, we kindly ask you to apply exclusively online by clicking the APPLY button at the bottom of the announcement. If for technical reasons you cannot apply online, please contact our Recruitment unit, which will assist you in your process at 021 / 314-85-70 from 08:30 to 12:00 and from 14:00 to 16:30.

CHUV applies the highest quality standards in its recruitment processes. Furthermore, committed to promoting diversity among our collaborators, we pay attention to different life paths and do everything possible to ensure equal treatment and avoid any discrimination. We look forward to receiving your application.

We kindly ask placement agencies to note that applications submitted directly by them on our recruitment platform are not accepted and cannot be invoiced. Thank you for your understanding.