Qualified Person (QP)

Solutions Driven; Bayern; Hybrid; EUR 100.000 - 150.000; Vollzeit

Zusammenfassung

Solutions Driven seeks an established Qualified Person to lead batch certification and release for EU market products from Germany. The role requires immediate, independent support with deep knowledge of German pharma legislation, robust GMP experience, and strong collaboration with quality, regulatory, and manufacturing teams.

You will oversee batch releases for solid dosage forms, generics, and biosimilars, review change controls and risk assessments, and support regulatory inspections while

Qualifikationen

• Strong, practical GMP experience.
• Solid knowledge of German pharmaceutical legislation and regulatory expectations.
• Fluent in English and German (C1 minimum).
• Capability to operate independently while collaborating with Quality, Regulatory, and Manufacturing functions.

Aufgaben

• Batch certification and release of products for the EU market in line with applicable EU directives.
• Oversee monthly batch releases across diverse dosage forms and biosimilars.
• Review and approve change controls, CAPAs, product quality reviews, recalls, and risk assessments.
• Support regulatory inspections and customer audits; drive GMP/GDP compliance improvements.
• Ensure QP review of test results prior to certification and release for both in-house and CMOs/CDMOs.

Kenntnisse

GMP experience

German regulatory knowledge

English proficiency

Independent working

Jobbeschreibung

Our client, a global pharmaceutical company with multi-billion-dollar revenue and 20,000+ employees worldwide, is looking to hire a Qualified Person within its Germany operations.

This is a business-critical hire. The organisation is losing its current incumbent QP and needs someone who can step in and provide independent, credible batch certification and release support from day one, no ramp-up period, no training wheels.

Note: Bavaria is not the exact location

The role

• Established Qualified Person, based in Germany's office (4 days in office)
• Batch certification and release of pharmaceutical products for the EU market, in line with Article 51 of Directive 2001/83/EC
• Oversight of the batches released per month, spanning solid oral dosage forms, generic injectables, and biosimilars
• Reviewing and approving change controls, critical market complaints, product recalls, Product Quality Reviews, and risk assessments
• Oversight across both internally manufactured and externally contracted products, with QP review of test results prior to certification and release
• Supporting regulatory inspections and customer audits, and driving continuous improvement across GMP and GDP compliance

What we're looking for

• Established Qualified Person status. This is not a role for a QP in training; the organisation needs immediate, independent support
• Strong, practical experience with German pharmaceutical legislation
• Solid GMP experience is essential; GDP knowledge is useful but secondary
• Pharmaceutical industry background is mandatory (adjacent industries such as chemicals won't transfer, even with strong manufacturing experience)
• Experience with CMOs/CDMOs is highly valued
• Biosimilars experience would be a strong plus
• Fluent in English and German (C1 minimum)
• Comfortable operating independently, and equally comfortable as a collaborative partner across quality, regulatory, and manufacturing functions

Why this role

A genuinely important technical role with direct responsibility for maintaining quality and compliance across the German organisation, and visibility across wider European quality operations, including CMO/CDMO relationships. Our client is deliberately looking for someone earlier in their QP career than the outgoing incumbent, which brings real scope for the role, and the responsibility that comes with it, to grow over time.