Head of QC

QP Group; Berlin; Vor Ort; EUR 120.000 - 160.000; Vollzeit

Zusammenfassung

QP Group, Berlin-based, is seeking a Head of Quality Control to own the QC function for biologics drug product and drug substance. You will lead routine testing, method lifecycle, and quality oversight in a GMP environment, interfacing with Manufacturing, MSAT, QA, and Regulatory to ensure on-time supply.

The role requires leadership of a multidisciplinary team, deep QC expertise in biologics analytics, and strong knowledge of EMA/FDA/ICH requirements.

Qualifikationen

• Proven leadership of QC in GMP biologics manufacturing.
• Expertise in biologics analytics (HPLC/UPLC, CE-SDS, SEC, LC-MS, ELISA).
• Strong knowledge of EMA, FDA, and GMP requirements.
• Experience owning batch release and stability programmes.
• Fluent English; German language considered an advantage.

Aufgaben

• 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.

Kenntnisse

QC leadership

GMP Biologics

Biologics analytics

Batch release

Method validation

Data integrity

GxP knowledge

Regulatory collaboration

English fluency

Jobbeschreibung

*** 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