P2614 Pharmaceutical Quality (pQM) Specialist

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 were 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.

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.

What we Offer:

Being part of a company where innovation collaboration and impact arent just values theyre 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 youll 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 Workablecheck your spam folder for emails from *@.

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

Required Experience:

IC