Qualified Person (QP)

Overview

A prominent global pharmaceutical corporation, generating multi-billion-dollar revenues and employing over 20,000 people worldwide, is actively seeking an experienced Qualified Person to join its Germany-based team. This vital position demands an immediate, autonomous professional capable of conducting batch certification and product release without the need for onboarding or training. Please note, the job location is in Bavaria, Germany, though the exact site is unspecified.

Key Responsibilities

• Act as an established Qualified Person located primarily in the office in Germany (working four days per week onsite).
• Conduct batch certification and authorise the release of pharmaceutical products destined for the EU market, complying strictly with Article 51 of Directive 2001/83/EC.
• Oversee batch releases monthly, covering a variety of pharmaceutical forms including solid oral dosage, generic injectable drugs, and biosimilars.
• Review and approve essential quality documentation such as change controls, major market-related complaints, product recalls, Product Quality Reviews, and risk assessments.
• Supervise both internally produced goods and those manufactured under contract by third parties, ensuring all batch testing outcomes are reviewed before certification and release.
• Support preparations and responses for regulatory inspections and customer audits, while leading initiatives for ongoing improvements in Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) compliance.

Candidate Profile

• Must hold official Qualified Person status; this position is not suitable for candidates still in training.
• Proven knowledge and hands-on experience with German pharmaceutical law is essential.
• Strong background in GMP is mandatory; familiarity with GDP is advantageous but not critical.
• Experience within the pharmaceutical industry is required; expertise from related sectors such as chemical manufacturing is not transferable for this role.
• Demonstrated experience working with Contract Manufacturing Organisations (CMOs) or Contract Development and Manufacturing Organisations (CDMOs) is highly desirable.
• Experience in biosimilars is a significant plus.
• Fluency in English and German at a minimum C1 proficiency level is required.
• Ability to work independently, while also collaborating effectively with quality assurance, regulatory affairs, and manufacturing teams.

Role Significance

This position holds critical responsibility for guaranteeing quality and regulatory compliance within the German division, and also extends influence to broader European quality operations, including collaborating with CMOs and CDMOs. The organisation seeks a candidate earlier in their Qualified Person career trajectory than the previous incumbent, offering a role with considerable room for professional growth and increasing responsibility.

Additional Information

This recruitment process is managed on an exclusive and confidential basis. Interested candidates will receive further comprehensive information, including the company name, following initial expressions of interest.