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Quality Assurance Manager
hace 3 meses
Barcelona
Barcelona, Catalonia, ES Our client's platform technology enables the efficient delivery of large genes using adeno-associated vectors (AAV).
The company overcomes one of the main limitations of AAV, which is their small packaging capacity, allowing the development of treatments for several diseases for which there are currently no treatments.
The company has completed the largest Series A financing ever in the Spanish biotech sector.Our client is looking for a Quality Assurance Manager , with experience in pharma / biotech who, reporting to the VP of QA & RRAA will be responsible for establishing and developing quality systems and shaping the quality culture of the organization in their headquarters in Barcelona.
Main Responsibilities:
Establish a culture of compliance and collaboration through the implementation and improvement of quality processes. Oversee and manage all GxP Quality tasks with input and support from external QA consultants/specialists as required. Lead the development of pharmaceutical quality systems - aligning policies, processes and procedures for internal and outsourced activities. Preparation of Quality Documents (e. g. SOPs, Policies, Forms and Templates) in conjunction with Subject Matter Experts as required.
Assure that all outsourced manufacturing activities and product testing are appropriate and conducted in accordance with company policies and GxP standards.
Ensure quality agreements with key suppliers and partners are complete, approved and updated at appropriate intervals. Provide guidance on investigations and corrective and preventive action (CAPA) plans for compliance issues and/or observations. Support development of company training programs for GxP-related procedures, practices and system requirements. Remain current with quality management trends and ensure that the company's quality systems evolve accordingly. Lead the Quality Management Review Process.Required Qualifications & Experience:
Degree in biopharma or related field Minimum 5+ years in Quality Assurance in the pharma/ biotech industry. Experience establishing and/or enhancing development of GxP quality infrastructure and systems compliant with EU and US regulations. Experience in overseeing GMP manufacturing activities at CDMOs (experience of Biologics, preferably ATMPs and advantage). Experience of GCP and/or GMP inspections. Extensive knowledge of EU and US GMP, GCP and GLP. Knowledge and experience in negotiating quality agreements and managing vendor relationships and performance. Knowledge of quality risk assessment and management methodologies, including successful application and risk remediation an advantage. Strong management and interpersonal/communication skills. Prior success in working effectively with senior scientific, medical and operations staff. Fluency in English, and Spanish is also preferred.
