# P2614 - Pharmaceutical Quality (pQM) Specialist

> Debiopharm · Lausanne, Switzerland · Full-time · Posted 2026-05-05

**Workplace:** on_site

**Department:** Contrôle Qualité

## Description

### Together, we innovate, we impact, we grow !

_**At Debiopharm, every step we take is guided by one purpose: improving the lives of people affected by cancer and infectious diseases. As a privately-owned Swiss biopharmaceutical company, we’re driven by science, but above all, by the people behind every treatment — the patients and their families.**_

_**Through our unique “development only” model, we bring forward promising therapies and transform them into treatments that can reach those who need them most, faster.**_

We are currently seeking a dedicated professional to join our Quality Management – R&D team  in **Lausanne, Switzerland**. In this role, you will be a key contributor to our Pharmaceutical Quality Unit (pQM), providing essential GMP support to development projects and external manufacturing partners, as a

### **Pharmaceutical Quality (pQM) Specialist**

**Permanent role | Lausanne, Switzerland**

### **Your Mission:**

Your primary goal is to ensure robust oversight of quality documentation and vendor activities while strengthening our **Pharmaceutical Quality System (PQS)**. You will help drive an agile, fit-for-purpose PQS that supports the high-quality development of investigational medicinal products for our patients.

### **Your Key Responsibilities**

·       **External Partnership Management:** Contribute to the preparation, negotiation, and implementation of Quality Agreements with CDMOs. 

·       **Project Representation:** Act as the pQM representative for assigned development projects, offering GMP guidance throughout the product lifecycle. 

·       **Quality Documentation:** Manage the lifecycle of pharmaceutical quality documentation and oversee the archiving and verification of Batch Record Review files. 

·       **System Operations:** Support Quality Leads in managing deviations, CAPAs, change controls, and OOS/OOT events. 

·       **Compliance & Inspection:** Collaborate with internal teams and CDMOs to ensure inspection readiness and support quality risk management activities.

·       **Continuous Improvement:** Help draft SOPs, coordinate GMP training, and analyze quality KPIs to enable data-driven decision-making.

## Requirements

### **Your Profile**

·       **Education:** University degree in Pharmaceutical Sciences, Chemistry, Life Sciences, or a related field. 

·       **Background:** Proven experience from at least 3-5 years in GMP operations within pharmaceutical development, QA/QC, or CDMO environments. 

·       **Technical Knowledge:** A solid understanding of EU GMP, ICH guidelines, and quality system elements.

·       **Preferred Skills:** Experience with deviations, CAPA, and batch record review is considered a strong advantage. 

·       **Soft Skills:** Strong analytical and organizational skills with the ability to work both autonomously and within cross-functional teams. 

·       **Collaboration:** Great ability to build and maintain strong working relationships across departments, and to influence cross-functional stakeholders to ensure quality compliance and project alignment

·       **Languages:** Fluent in both English and in French.

## Benefits

**What we Offer:**

·       Being part of a company where innovation, collaboration, and impact aren’t just values — they’re how we work every day

·       Partner with teams across disciplines, at the forefront of oncology and anti-infective development

·       An inclusive and respectful workplace — proud to be Equal-Pay certified

·       Grow in a culture that values people, purpose, and performance

·       A chance to grow, share, and shape the future of healthcare

**What to Expect in the Recruitment Process:**

If your application is selected, you’ll be invited to interviews with Talent Acquisition and the Hiring Manager via Teams, followed by a panel interview and reference checks. Communication is handled via Workable—check your spam folder for emails from _\*@outbound.workable.com_.

_Please contact our HR Department prior to submitting any profiles. We cannot accept unsolicited applications from agencies or recruiters._

## Apply

[Apply at Debiopharm](https://apply.workable.com/debiopharm/j/36249F2C30/apply)

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