Senior Manager CQA (all genders) – fulltime, permanent
Core
Leading quality compliance and operational excellence for a complex commercial pharmaceutical entity in Europe, ensuring adherence to German regulations and managing Wholesale Distribution Authorization.
Role type
Senior Manager, Quality Assurance (CQA)
Builds
Robust quality systems, procedures, and processes for drugs, biologics, and combination products.
Domain
Pharmaceutical industry, Quality Assurance, Regulatory Compliance
Deliverable
client delivery
Required skills
Team leadership and management, GxP-regulated environment expertise, German and English business fluency, regulatory requirements knowledge for finished products, stakeholder management, risk management, supplier management, inspection and audit management.
Preferred skills
Experience in operations, coaching team members, driving continuous improvement, fostering leadership development.
Technologies
None stated
Responsibilities
Provide leadership and oversight of quality compliance matters at an operational and regulatory level; oversee quality at the affiliate level and manage MAH responsibilities for centrally filed products in Europe; integrate and support German regulations for drugs, biologics, devices, and combination products; drive the design of effective quality systems and processes; manage the Wholesale Distribution Authorization (WDA) and host inspections and audits; manage and oversee a team including hiring, performance feedback, and development.
Seniority
Senior, hands-on IC with team management