Senior Quality Operations Manager

hace 4 días


Madrid, Madrid, España Takeda Pharmaceutical A tiempo completo

**Job Summary:**
We are seeking a highly skilled Senior Quality Specialist to join our team at Takeda Pharmaceutical. This role will be responsible for ensuring the quality of our products and services, in line with local and international regulations.

**About the Role:**
This is a senior-level position that will oversee quality activities related to Takeda Products commercial activities at Takeda Iberia Local Operating Company (LOC). The successful candidate will ensure that a quality management system is implemented and maintained in accordance with relevant guidelines, regulations, and standards.

**Key Responsibilities:**

  • Quality oversight of outsourced distribution partners
  • Ensure compliance with legal and corporate requirements, as well as I-SOPs and Local SOPs
  • Establish corrective and preventive actions and promote continuous improvement in critical processes from a quality point of view
  • Local quality surveillance - connect with customers: Returns, market actions, complaints, inquiries
  • Local MOH relationship - Good Distribution Practices inspections & work closely with RA in MOH communications
  • Support geographic expansions and brand plan launches
  • Shipping validation and distribution processes quality oversight
  • Identify risks in the quality area, propose CAPA, and follow up
  • Interact with local stakeholders: Supply Chain & Customer service, Customers, Pharmacovigilance, Regulatory Affairs, Compliance, Suppliers, Medical Affairs, Marketing

**How You Will Contribute:**
  • Quality Management System: Batch release documentation of the company products to ensure quality, including incidences and complaints solving
  • Training activities in the quality area and management of staff training records for GxP positions
  • Change Control & CAPA management and monitoring
  • Management Review Systems, Quality Council meetings. Collaboration in QMS maintenance
  • Market action management and handling of returns
  • Control of damaged and broken products
  • Local Complaint Coordinator & management of counterfeit products
  • Responsible for annual environmental declarations
  • Supplier approval and maintenance
  • Ensure timely delivery of fully compliant products applicable to local regulations

**What You Bring to Takeda:**
  • Bachelor's Degree in Pharmacy
  • Practical experience of at least 6 years in the Pharmaceutical Industry, primarily in a QA environment
  • Experience in supporting inspections from local authorities/global audits
  • Strong interpersonal skills and the ability to work cross-functionally and cross-culturally
  • Good knowledge of Pharmaceutical Quality Management systems: EU GDPs, ISO standards, GMPs
  • Excellent verbal and writing skills and fluent in English

**Salary Range:** €60,000 - €80,000 per year, depending on experience

**Location:** Takeda Iberia Local Operating Company (LOC)

**Benefits:**
  • Competitive salary
  • Comprehensive benefits package
  • Ongoing training and development opportunities
  • Opportunities for career growth and advancement

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