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, 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.