We are currently recruiting on behalf of an innovative, fast-growing global biopharmaceutical company dedicated to bringing life-changing therapies to patients worldwide. Operating at the cutting edge of science, our client fosters an agile, collaborative culture where quality excellence, continuous improvement, and cross-functional synergy drive everything they do. If you are looking to join a high-impact team that values ownership and professional growth, this is the environment for you.

The Role: Regional Quality & Distribution Specialist (EU)

We are looking for a proactive and detail-oriented Quality professional to oversee Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) for commercial products across the EU and international markets.

In this dynamic position, you will serve as a vital link between cross-functional teams, contract manufacturers, and 3PL partners—ensuring seamless compliance, robust quality oversight, and the safe, compliant release and distribution of life-saving medicines.

Key Responsibilities

1. Batch Review & GDP Release Operations

• EU QP Batch Certification Support: Lead batch review and release preparation for commercial APIs, primary packed products, and finished products (manufactured internally or via CMOs).

• Distribution Management: Oversee GDP releases post-QP certification, conduct customer/wholesaler approvals, and directly support in-country distributors and 3PLs.

• Excursion & Deviation Handling: Rapidly assess, manage, and monitor temperature excursions, deviations, and product complaints.

2. Quality Oversight & Cross-Functional Collaboration

• Root-Cause Investigations: Lead and troubleshoot critical quality investigations with internal/external partners, ensuring robust CAPAs are put in place.

• Agreement Execution: Drive, draft, and maintain high-standard Quality Agreements with European stakeholders, ensuring alignment with GMP/GDP regulations and internal standards.

• Management Reviews & KPIs: Retrieve, analyze, and present key quality performance metrics to Regional Directors and Functional Managers to foster continuous improvement.

• Stakeholder Alignment: Work in tight collaboration with EU Qualified Persons (QPs) (per Directive 2001/83/EC) and Swiss Responsible Persons (RPs) to ensure full compliance across territories.

3. Compliance, Inspections & Continuous Improvement

• Support Health Authority Inspections and Audits (and internal regulatory filings) as a subject matter expert.

• Collaborate cross-functionally with Manufacturing, Supply Chain, and Regulatory teams to resolve complex operational anomalies.

• Participate in updating global quality policies, developing training materials, and tracking quality metrics.

What You Bring to the Team

• Experience: minimum 3 years in the pharmaceutical or biotechnology industry, with strong GMP/GDP quality experience (commercial stage strongly preferred).

• IMP Knowledge: Experience working with Investigational Medicinal Products.

• Regulatory Expertise: In-depth knowledge of global and local EU GMP/GDP guidelines and regulations.

• Education: Bachelor’s degree in a scientific discipline (or equivalent practical work experience).

• Languages: Fluent in English is required; fluency in German is a strong advantage.

• Soft Skills: Exceptional interpersonal skills—strong listening, writing, negotiation, facilitation, and a keen eye for detail.

Why Apply?

• High Visibility & Impact: Play a pivotal role in ensuring medicine quality across the European region.

• Dynamic Scope: Work across a broad spectrum of GxP operations, from CMO management to direct regulatory alignment.

• Growth Culture: Join an energetic team that empowers you to take ownership of challenges and drive solutions.