Head of QC in Berlin

*** Head of QC Opportunity - Biologics ***

QP Group is partnered with a well-backed biologics organisation based in Berlin, investing significantly in its in-house drug product manufacturing and quality capability. The business is scaling its GMP operations and building out the teams, systems, and facilities that will underpin clinical and commercial supply. This is a genuine build phase, offering the incoming Head of QC the opportunity to shape the function, embed best-practice quality systems, and grow a department rather than inherit a fixed structure. The environment is scientifically ambitious, modality-diverse across biologics, and firmly focused on regulatory-ready, right-first-time quality.

The Role

Reporting into senior site leadership, the Head of Quality Control will own the full QC function for biologics drug product and drug substance, leading routine testing, method lifecycle, and quality oversight in a GMP environment. The role sits at the interface of manufacturing, MSAT, and QA, and carries accountability for the timely, compliant release of material.

Key Responsibilities:

• Lead and build the QC department across analytical, potency, and microbiology/environmental monitoring disciplines
• Own QC testing and data review supporting batch disposition, release, and stability programmes
• Direct method development, qualification, validation, and transfer for biologics
• Ensure inspection and audit readiness for EMA, FDA, and other health authorities
• Manage deviations, OOS/OOT investigations, CAPAs, and change control within the QC remit
• Oversee equipment qualification, computerised system validation, and data integrity
• Partner with Manufacturing, MSAT, QA, and Regulatory to enable robust, on-time supply
• Recruit, mentor, and develop a multidisciplinary QC team
• Contribute to QC facility, capacity, and capability expansion

Experience Required:

• Proven QC leadership within a GMP biologics manufacturing or drug product environment
• Deep expertise across biologics analytics such as HPLC/UPLC, CE-SDS, SEC, LC-MS, ELISA, and cell-based potency assays
• Strong command of ICH, EMA, FDA, and GMP requirements
• Experience owning batch release and stability programmes for biologics
• Track record leading method validation, transfer, and quality systems
• Demonstrated success managing and growing scientific teams
• Fluent English; German an advantage
• Comfortable operating in a scale-up, build-oriented setting