QP manager

We're looking for a Qualified Person (QP) to take responsibility for product release, regulatory compliance, and collaboration across key departments. In this role, you'll play a vital part in maintaining high-quality standards, driving process improvements, and representing the QP function in inspections and audits.

Your Responsibilities

• Responsible for the release of manufactured products in compliance with legal requirements (§14 AMG, Annex 16) as a Qualified Person (QP).
• Assessment and approval of GMP-relevant documents, including SOPs, PQRs, change control applications, deviations, complaints, and CAPAs.
• Key point of contact for GMP and regulatory compliance questions.
• Close collaboration with manufacturing, packaging, and quality control departments.
• Participation in project teams to enhance quality-related systems and processes.
• Communication with clients and regulatory authorities, representing the QP function during inspections and audits.

Your Profile

• Pharmacy license with required expertise (§15 AMG).
• Strong knowledge of pharmaceutical law and current GMP regulations.
• Independent and structured workstyle with high responsibility awareness.
• Analytical, strategic thinking, process and quality orientation, and problem-solving skills.
• Passion for process improvement, ensuring compliance and efficiency.
• Appreciation for flexibility and agility in a fast-growing company.
• Fluent English (spoken & written).

What We Offer

• Stable, growing pharmaceutical company.
• Flat hierarchies with quick decision-making in a supportive environment.
• Autonomy in a varied role with space for initiative.
• Numerous personal and professional development opportunities.