Product Quality Leader (all genders)

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Product Quality Leader (all genders), Darmstadt

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Job Category: Other

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EU work permit required: Yes

Job Reference:

af8494506643

Job Views:

1

Posted:

09.05.2025

Expiry Date:

23.06.2025

Job Description:

The Product Quality Lead (PQL) is responsible for providing quality oversight of Pharma products/franchises throughout the product and design control lifecycle. They develop, approve, monitor, and maintain critical quality standards to proactively minimize product quality and design control risks. The role ensures quality management of products and processes throughout their lifecycle, leads improvements, develops action plans related to Product Quality health, and aligns with current regulatory expectations.

The individual partners cross-functionally with stakeholders such as Supply Network Operations, Manufacturing Sciences & Technology, Global Regulatory Affairs, Site Regulatory Compliance, Healthcare Quality, and Global Pharma Manufacturing. They serve as the Quality representative on relevant CMC boards to enable efficient communication and strategic decision-making related to product quality.

Responsibilities include providing quality oversight and strategic guidance throughout the CMC lifecycle management of Pharma drug substances and drug products, acting as a Quality representative in cross-functional forums, supporting and overseeing internal manufacturing and testing facilities, and managing overall success against strategic plans, including lifecycle, footprint, risks, and business continuity. The role also involves monitoring product scorecards, supporting significant changes and deviations, managing CPA, deploying controls for risk-based process verification, and ensuring timely escalation and mitigation of risks. Additionally, the role partners with Digital teams to identify and implement efficiency tools.

Who you are:

• Bachelor's degree, preferably in Sciences or Engineering, with at least 10 years of relevant industry experience in Quality.
• Working knowledge of EU, China, and Japan regulations, MHRA, FDA, ICH standards, and experience supporting regulatory inspections.
• Knowledge of design controls, risk management, and quality system requirements.
• Experience with control charts, statistics, process validation, and data trending using statistical software.
• Effective interaction skills across all organizational levels.
• Proven project and team management skills for complex scopes, meeting all deliverables and timelines.
• Excellent interpersonal and communication skills.
• Ability to navigate ambiguity, adapt to rapid growth, and collaborate in a dynamic, cross-functional environment.