Senior Manager CQA (all genders) – fulltime, permanent
Full-time Mid-Senior LevelJob Overview
In our Quality Assurance team in Ludwigshafen, you will join a group of experienced professionals dedicated to ensuring quality, compliance, and operational excellence across a complex commercial pharmaceutical environment. Working at the interface of local quality oversight, MAH responsibilities for centrally filed products in Europe, and cross-functional collaboration, you will help shape robust quality systems and drive continuous improvement. If you are passionate about leading teams, navigating regulatory complexity, and partnering with stakeholders across the business to enable compliant and efficient operations, we invite you to join us as Senior Manager CQA (all genders)!
Your Responsibilities:
- Providing leadership and oversight of quality compliance matters at an operational and regulatory complex commercial entity
- Oversight of quality at the affiliate level as well as MAH responsibilities for centrally filed products in Europe
- Integration and support of German regulations at the affiliate level for drugs, biologics, device and/or combination products
- Driving the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency
- Managing the Wholesale Distribution Authorization (WDA) and hosting internal, external and MoH inspections & audits in support of this licence
- Responsible for the management and oversight of a team including hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues
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