Manufacturing Lead, EU GMP Operations

BioTalent; Düsseldorf; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A global pharmaceutical organization is looking for a Manufacturing Lead to oversee EU GMP operations in Düsseldorf. You will manage manufacturing activities, ensure compliance with regulatory standards, and support QP release processes. The ideal candidate has a degree in a related field, at least 3 years of pharmaceutical manufacturing experience, and is fluent in German and English. This role offers visibility and impact across EU operations.

Qualifikationen

• At least 3 years of hands-on pharmaceutical manufacturing experience.
• Experience reviewing manufacturing records and supporting QP release.
• Background working with external manufacturing partners or CMOs.

Aufgaben

• Managing manufacturing activities in line with AMWHV §12.
• Ensuring timely import, testing, and review of batch records.
• Supporting GMP and GDP compliance across all operational areas.
• Working closely with external manufacturers and packagers.
• Overseeing documentation, deviations, CAPA, audits, and change control.
• Supporting qualification and validation of equipment and processes.
• Preparing documentation required for QP release.

Kenntnisse

Fluent German

Fluent English

Strong organizational skills

Documentation skills

Problem-solving skills

Ausbildung

Degree in pharmacy, chemistry, pharmaceutical technology, or related field

Jobbeschreibung

Manufacturing Lead, EU GMP Operations

PLEASE NOTE : Applicants must be fluent in both German and English and currently based in Germany . You must also have hands‑on experience with commercial medicinal products and / or IMPs across solid, liquid, and ideally sterile manufacturing, along with a solid understanding of EU importation and QP release standards.

BioTalent are teamed up with a global pharmaceutical organisation that are expanding its EU import and manufacturing oversight function and is looking for a Manufacturing Lead to join the team. The focus of this role is to ensure that imported and manufactured medicinal products meet EU GMP, GDP, and national regulatory requirements, with a strong emphasis on batch review, documentation control, partner oversight, and supporting QP release activities.

This is a great fit for someone who enjoys working across manufacturing, QA, external partners, and regulatory expectations, and wants a role with real visibility and impact across EU operations.

What you’ll be doing

• Managing manufacturing activities in line with AMWHV §12
• Ensuring timely import, testing, and review of batch records
• Supporting GMP and GDP compliance across all operational areas
• Working closely with external manufacturers, packagers, and contract service providers
• Overseeing documentation, deviations, CAPA, audits, and change control
• Supporting qualification and validation of equipment, facilities, and processes
• Preparing documentation required for QP release
• Working with QA and operational teams to streamline and strengthen processes

What you’ll need

• Degree in pharmacy, chemistry, pharmaceutical technology, or a related field
• At least 3 years of hands‑on pharmaceutical manufacturing experience (solid, liquid, or sterile dosage forms)
• Experience reviewing manufacturing records and supporting QP release processes
• Background working with external manufacturing partners or CMOs
• Fluent German and English
• Strong organisational, documentation, and problem‑solving skills
• Willingness to travel occasionally and attend the Munich site when needed